U.S. patent number 9,044,223 [Application Number 13/488,664] was granted by the patent office on 2015-06-02 for implant insertion systems and methods of use.
This patent grant is currently assigned to ETHICON, INC.. The grantee listed for this patent is Trevor Brian Akehurst, Jessica Liberatore, Robert Nering, Michael Nordmeyer, Daniel Joseph Smith. Invention is credited to Trevor Brian Akehurst, Jessica Liberatore, Robert Nering, Michael Nordmeyer, Daniel Joseph Smith.
United States Patent |
9,044,223 |
Smith , et al. |
June 2, 2015 |
Implant insertion systems and methods of use
Abstract
An implant insertion system includes an implant, such as a
surgical mesh, having at least one insertion tip secured to the
implant. Each insertion tip has a tapered distal end, a proximal
end, a base extending proximally from the tapered distal end, and a
central lumen formed in the base having an opening facing the
proximal end of the insertion tip. The system includes an insertion
device having an outer shaft and a latching assembly provided at a
distal end of the outer shaft that is insertable into the opening
of the central lumen for selectively locking the insertion tip to
the latching assembly. The latching assembly has an outer dimension
that is changeable from expanded state for locking the insertion
tip to the latching assembly to a non-expanded state for unlocking
the insertion tip from the latching assembly.
Inventors: |
Smith; Daniel Joseph (Dayton,
NJ), Nering; Robert (Stockton, NJ), Nordmeyer;
Michael (Pittstown, NJ), Liberatore; Jessica (San Mateo,
CA), Akehurst; Trevor Brian (Bury St Edmunds,
GB) |
Applicant: |
Name |
City |
State |
Country |
Type |
Smith; Daniel Joseph
Nering; Robert
Nordmeyer; Michael
Liberatore; Jessica
Akehurst; Trevor Brian |
Dayton
Stockton
Pittstown
San Mateo
Bury St Edmunds |
NJ
NJ
NJ
CA
N/A |
US
US
US
US
GB |
|
|
Assignee: |
ETHICON, INC. (Somerville,
NJ)
|
Family
ID: |
48741483 |
Appl.
No.: |
13/488,664 |
Filed: |
June 5, 2012 |
Prior Publication Data
|
|
|
|
Document
Identifier |
Publication Date |
|
US 20130324789 A1 |
Dec 5, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
17/06109 (20130101); A61F 2/0045 (20130101); A61B
2017/00477 (20130101); A61B 2017/0409 (20130101); A61B
17/3468 (20130101); A61B 2090/033 (20160201); Y10S
128/25 (20130101); A61B 2017/00367 (20130101); A61B
2017/00805 (20130101) |
Current International
Class: |
A61F
2/00 (20060101) |
Field of
Search: |
;600/37,29,30 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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2353220 |
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Feb 2001 |
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GB |
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02071953 |
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Sep 2002 |
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WO |
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2011106419 |
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Sep 2011 |
|
WO |
|
Other References
"Gynecare TVT Abbrevo Continence System," Ethicon, Inc.,
www.ethicon.com/healthcare-professionals/products/gyncology-solutions,
Jul. 1, 2013, 1 page. cited by applicant .
"Ophira Mini Sling System," Promedon, www.promedon.com, 2013, 5
pages. cited by applicant .
"MiniArc Single-Incision Sling," American Medical Systems,
www.americanmedicalsystems.com, Jul. 1, 2013, 3 pages. cited by
applicant .
"MiniArc Precise Single-Incision Sling," American Medical Systems,
www.americanmedicalsystems.com, 2013, 3 pages. cited by applicant
.
"Solyx SIS System," Boston Scientific Corporation,
www.bostonscientific.com/gynecology, 2009, 4 pages. cited by
applicant .
International Search Report issued for International Application
No. PCT/US2013/043541, mailed Oct. 1, 2013, 9 pages. cited by
applicant.
|
Primary Examiner: Marmor, II; Charles A
Assistant Examiner: McBride; Shannon
Claims
What is claimed is:
1. An implant insertion system comprising: an implant; at least one
insertion tip secured to said implant, coach said at least one
insertion tip having a tapered distal end, a proximal end, a base
extending proximally from said tapered distal end, and a central
lumen formed in said base having an opening facing the proximal end
of said insertion tip; an insertion device having an outer shaft
and a latching assembly provided at a distal end of said outer
shaft that is insertable into the opening of the central lumen for
selectively locking said insertion tip to said latching assembly,
said latching assembly having first and second latches at the
distal end thereof defining an outer dimension that is changeable
from an expanded state for locking said insertion tip to said
latching assembly to a non-expanded state for unlocking said
insertion tip from said latching assembly, wherein said first and
second latches are elastic, normally flex inwardly toward one
another, and have inner cam surfaces that oppose one another; and a
tip pin disposed within a central opening of said latching assembly
that extends between proximal and distal ends of said latching
assembly, said tip pin having a shaft with a larger diameter
section and a smaller diameter section, wherein said tip pin is
moveable toward the proximal end of said latching assembly so that
the larger diameter section of said shaft engages said inner cam
surfaces for moving said first and second latches away from one
another into the expanded state, and wherein said tip pin is
moveable toward the distal end of said latching assembly so that
the smaller diameter section of said shaft is aligned with said
inner cam surfaces whereupon said first and second latches flex
inwardly toward one another into the non-expanded state.
2. The implant insertion system as claimed in claim 1, wherein when
said latching assembly is in the expanded state the outer dimension
of said latching assembly is greater than an inner dimension of the
central lumen of said insertion tip.
3. The implant insertion system as claimed in claim 1, wherein when
said latching assembly is in the non-expanded state the outer
dimension of said latching assembly is less than or equal to an
inner dimension of the central lumen of said insertion tip.
4. The implant insertion system as claimed in claim 1, wherein the
central lumen of said insertion tip has a width, and wherein said
latching assembly is wider than the width of the central lumen when
said latching assembly is in the expanded state and narrower than
or equal to the width of the central lumen when said latching
assembly is in the non-expanded state.
5. The implant insertion system as claimed in claim 1, wherein said
latching assembly has said proximal end attached to the distal end
of said outer shaft, and wherein said first and second latches have
respective first and second latch posts that project away from one
another.
6. The implant insertion system as claimed in claim 1, further
comprising first and second windows formed in said base of said
insertion tip, wherein said first and second windows are formed in
opposing side walls of said base of said insertion tip, and wherein
said first and second windows oppose one another and intersect with
the central lumen formed in said base of said insertion tip.
7. The implant insertion system as claimed in claim 6, wherein said
base of said insertion tip further comprises a blind pocket at a
distal end of said central lumen and distal to said first and
second windows, wherein said blind pocket is adapted to receive
latch extensions at distal ends of said first and second latches
when said insertion tip is secured to said latching assembly.
8. The implant insertion system as claimed in claim 7, wherein in
the expanded state said first and second latch posts extend into
said first and second windows in said base of said insertion tip
for locking said insertion tip to said latching assembly.
9. The implant insertion system as claimed in claim 8, said tip pin
having a proximal end, a distal end, said shaft extending between
the proximal and distal ends, a reduced diameter neck formed in
said smaller diameter section of said shaft, and an annular base at
the proximal end of said tip pin, wherein said reduced diameter
neck of said tip pin has a diameter that is smaller than the larder
diameter section of said shaft located at the proximal and distal
ends of said tip pin, and said annular base of said tip pin has a
diameter that is greater than the larder diameter section of said
shaft at the proximal and distal ends of said tip pin and greater
than the diameter of said central opening of said latching
assembly.
10. The implant insertion system as claimed in claim 9, wherein
said tip pin comprises metal and is freely moveable within the
central opening of said latching assembly for sliding in proximal
and distal directions within the central opening of said latching
assembly.
11. The implant insertion system as claimed in claim 9, wherein
said first and second latches have said inner cam surfaces that
slide over the outer surface of said tip pin shaft, wherein when
said latching assembly is in the non-expanded state, the distal end
of said tip pin is distal to the distal end of said latching
assembly and said inner cam surfaces of said first and second
latches are in contact with said reduced diameter neck of said tip
pin, and when said latching assembly is in the expanded state the
distal end of said tip pin is aligned with the distal end of said
latching assembly and said inner cam surfaces of said first and
second latches are in contact with the larder diameter section of
said tip pin shaft adjacent the distal end of said tip pin.
12. The implant insertion system as claimed in claim 11 wherein
said insertion device further comprises: a handle having a proximal
end and a distal end, wherein a proximal end of said outer shaft is
secured to the distal end of said handle; an actuator provided on
said handle and being moveable between the proximal and distal ends
of said handle, said actuator having a ramp and said handle having
a flexible element that engages said ramp for generating a
detectable click when said actuator is moved to a distal-most
position for indicating that said latching assembly is in the
non-expanded state.
13. The implant insertion system as claimed in claim 12, further
comprising: said outer shaft having an elongated conduit extending
between the proximal and distal ends thereof; and a push wire
disposed within the elongated conduit of said outer shaft and being
moveable in distal and proximal directions relative to said outer
shaft, said push wire having a proximal end opposing said actuator
and a distal end opposing said annular base of said tip pin,
wherein said push wire is not connected with said actuator or said
tip pin, and wherein said push wire is free to slide in distal and
proximal directions within the elongated conduit of said outer
shaft.
14. The implant insertion system as claimed in claim 13, wherein
said outer shaft comprises metal, said latching assembly comprises
a polymer material, said tip pin comprises metal, said implant
comprises mesh or a mesh and suture combination, said insertion tip
comprises a polymer, and said push wire is flexible and is selected
from the group of materials consisting of stainless steel,
polymers, nylon, Teflon, polypropylene and combinations
thereof.
15. The implant insertion system as claimed in claim 13, wherein
said insertion tip is locked onto said latching assembly by placing
the central lumen of said insertion tip over the distal end of said
latching assembly and pushing said insertion tip toward the
proximal end of said latching assembly for forcing said tip pin to
move proximally, which, in turn, urges said first and second
latches away from one another.
16. The implant insertion system as claimed in claim 15, wherein
said insertion tip is unlocked from said latching assembly by
moving said actuator toward the distal end of said handle, which,
in turn, urges said push wire distally for contacting said annular
base of said tip pin, which, in turn, urges said tip pin distally
for aligning said reduced diameter neck of said tip pin with said
inner cam surfaces of said first and second latches so that said
first and second latches are free to flex inwardly toward one
another, wherein when said actuator moves from a proximal-most
position to a distal-most position said actuator travels about 4-5
times more than said push wire.
17. The implant insertion system as claimed in claim 1, wherein the
central lumen of said insertion tip has a blind pocket adjacent a
distal end of said base, a top wall that defines an upper surface
of the central lumen, a bottom wall that defines a lower surface of
the central lumen, and opposing side walls extending between the
top and bottom walls of the central lumen, and wherein said base of
said insertion tip has first and second windows that extend through
the side walls of the central lumen.
18. The implant insertion system as claimed in claim 17, wherein
said insertion tip includes an elongated flat surface that extends
proximally from the bottom wall of the central lumen to the
proximal end of said insertion tip, wherein when said latching
assembly is inserted into the central lumen said latching assembly
has a flat bottom surface that engages the bottom wall of the
central lumen and the distal end of said outer shaft has a flat
surface that engages said elongated flat surface that extends
proximally from the bottom wall of said central lumen to the
proximal end of said insertion tip.
19. The implant insertion system as claimed in claim 18, wherein
said insertion tip further comprises a hoop provided under said
elongated flat surface adjacent the proximal end of said insertion
tip, said hoop having a hoop opening for receiving an end of said
implant, wherein said hoop is collapsible and meltable for
conforming to an outer profile of said insertion tip.
20. The implant insertion system as claimed in claim 19, wherein
said hoop has opposing sidewalls with weakened sections that enable
said opposing sidewalls to collapse inwardly toward one another for
capturing said implant within said collapsed hoop.
21. The implant insertion system as claimed in claim 18, wherein
said latching assembly has a flat top surface that engages the top
wall of the central lumen of said insertion tip when said flat
bottom surface of said latching assembly engages the bottom wall of
the central lumen of said insertion tip for providing rotational
stability for said insertion tip when said insertion tip is locked
to a distal end of said insertion device.
22. An implant insertion system comprising: an implant having a
central section and first and second arms extending from opposite
sides of said central section; a first insertion tip secured to
said first arm of said implant and a second insertion tip secured
to said second arm of said implant, each said insertion tip having
a tapered distal end, a proximal end, a base extending proximally
from said tapered distal end, and a central lumen formed in said
base having an opening facing the proximal end of said insertion
tip; a first insertion device for securing said first insertion tip
and a second insertion device for securing said second insertion
tip, each said insertion device having an outer shaft and a
latching assembly provided at a distal end of said outer shaft that
is insertable into the opening of the central lumen of one of said
insertion tips for selectively locking the one of said insertion
tips to said latching assembly, said latching assembly having first
and second latches at the distal end thereof defining an outer
dimension that is changeable from an expanded state for locking the
one of said insertion tips to said latching assembly to a
non-expanded state for unlocking the one of said insertion tips
from said latching assembly; a tip pin disposed within a central
opening of said latching assembly, said tip pin being free to slide
distally and proximally within the central opening of said latching
assembly; a push wire disposed within said outer shaft and being
free to slide distally and proximally within said outer shaft,
wherein a distal end of said push wire opposes a proximal end of
said tip pin, and wherein said tip pin and said push wire are not
connected and are free to slide relative to one another in distal
and proximal directions.
23. The implant insertion system as claimed in claim 22, wherein
said first insertion device comprises a left-hand insertion device
for securing said first insertion tip and said second insertion
device comprises a right-hand insertion device for securing said
second insertion tip.
24. The implant insertion system as claimed in claim 23, wherein
when said left-hand and right-hand insertion devices are secured to
said first and second insertion tips, respectively, said outer
shaft of said left-hand insertion device has a distal end that
curves to the left and said outer shaft of said right-hand
insertion device has a distal end that curves to the right and away
from the distal end of said outer shaft of said left-hand insertion
device.
25. The implant system as claimed in claim 22, wherein said first
and second latches are elastic, normally flex inwardly toward one
another, and have inner cam surfaces that oppose one another,
wherein said tip pin has a shaft with a larger diameter section and
a smaller diameter section proximal to the larger diameter section,
wherein said tip pin is moveable proximally toward the proximal end
of said latching assembly so that the larger diameter section of
said shaft engages said inner cam surfaces for moving said first
and second latches away from one another into the expanded state,
and wherein said tip pin is moveable distally toward the distal end
of said latching assembly so that the smaller diameter section of
said shaft is aligned with said inner cam surfaces whereupon said
first and second latches flex inwardly toward one another into the
non-expanded state.
26. A method of treating urinary incontinence comprising: providing
a mesh implant having a central section and first and second arms
extending from opposite sides of said central section, said mesh
implant having a first insertion tip secured to said first arm and
a second insertion tip secured to said second arm, each said
insertion tip having a tapered distal end, a proximal end, a base
extending proximally from said tapered distal end, and a central
lumen formed in said base having an opening facing the proximal end
of said insertion tip; providing a first insertion device having a
first outer shaft and a first latching assembly having first and
second latches at the distal end thereof defining an outer
dimension that is changeable from a non-expanded state to an
expanded state, wherein said first and second latches are elastic,
normally flex inwardly toward one another, and have inner cam
surfaces that oppose one another; disposing a tip pin within a
central opening of said first latching assembly, said tip pin
having a shaft with a larger diameter section and a smaller
diameter section; inserting said first latching assembly into the
central lumen of said first insertion tip so that said first
insertion tip engages a distal end of said tip pin for moving said
tip pin toward the proximal end of said first latching assembly so
that the larger diameter section of said shaft engages said inner
cam surfaces of said first and second latches for moving said first
and second latches away from one another for changing the outer
dimension of said first latching assembly to the expanded state for
locking said first insertion tip to said first latching assembly;
providing a second insertion device having a second outer shaft and
a second latching assembly having first and second latches at the
distal end thereof defining an outer dimension that is changeable
from a non-expanded state to an expanded state, wherein said first
and second latches of said second latching assembly are elastic,
normally flex inwardly toward one another, and have inner cam
surfaces that oppose one another; and inserting said second
latching assembly into the central lumen of said second insertion
tip so that said second insertion tip engages a distal end of said
second tip pin for moving said second tip pin toward the proximal
end of said second latching assembly so that the larger diameter
section of said shaft of said second tip pin engages said inner cam
surfaces for moving said first and second latches of said second
latching assembly away from one another for changing the outer
dimension of said second latching assembly to the expanded state
for locking said second insertion tip to said second latching
assembly.
27. The method as claimed in claim 26, further comprising: forming
a surgical opening in tissue; while said first insertion tip is
locked to said first insertion device, inserting said first
insertion tip into the surgical opening for positioning said first
insertion tip at a first location in the tissue; while said second
insertion tip is locked to said second insertion device, inserting
said second insertion tip into the surgical opening for positioning
said second insertion tip in a second location in the tissue;
changing the outer dimension of said second insertion device from
the expanded state to the non-expanded state for unlocking said
second insertion tip from said second insertion device; while said
first insertion tip remains locked to said first insertion device,
moving the location of said first insertion tip to a third location
in the tissue for adjusting the location of said central section of
said mesh implant.
28. The method as claimed in claim 27, further comprising pushing
said first insertion tip into the tissue and pulling said first
insertion tip out of the tissue while said first insertion tip
remains locked to said first latching assembly.
29. The method as claimed in claim 28, further comprising after the
pushing and pulling, changing the outer dimension of said first
insertion device from the expanded state to the non-expanded state
for unlocking said first insertion tip from said first insertion
device.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to systems, devices and
methods for the treatment of female urinary incontinence, and more
particularly, to systems and methods for placing a sub-urethral
sling.
2. Description of the Related Art
Women account for more than 11 million incontinence cases, with a
majority of those women suffering from stress urinary incontinence
(SUI). Women with SUI involuntarily lose urine during normal daily
activities and movements, such as laughing, coughing, sneezing and
regular exercise.
SUI may be caused by a functional defect or weakened tissue or
ligaments connecting the vaginal wall with the pelvic muscles and
pubic bone. Common causes include repetitive straining of the
pelvic muscles, childbirth, loss of pelvic muscle tone, and
estrogen loss. Such a defect results in an improperly functioning
urethra. Unlike other types of incontinence, SUI is not a problem
of the bladder.
Normally, the urethra, when properly supported by strong pelvic
floor muscles and healthy connective tissue, maintains a tight seal
to prevent involuntary loss of urine. When a woman suffers from the
most common form of SUI, however, weakened muscle and pelvic
tissues are unable to adequately support the urethra in its correct
position. As a result, during normal movements when pressure is
exerted on the bladder from the diaphragm, the urethra cannot
retain its seal, permitting urine to escape. Because SUI is both
embarrassing and unpredictable, many women with SUI avoid an active
lifestyle and shy away from social situations.
One device and method for treating female urinary stress
incontinence is described in detail in U.S. Pat. No. 5,899,909,
which is incorporated herein by reference in its entirety. This
patent discloses a surgical instrument comprising a shank having a
handle at one end and connecting means at the other end to receive,
one at a time, two curved needle-like elements which each are
connected at one end to respective ends of a mesh intended to be
implanted into the body. In practice, the mesh is passed into the
body via the vagina first at one end and then at the other end, at
one side and the other, respectively, of the urethra to form a loop
around the urethra, located between the urethra and vaginal wall.
The mesh is extended over the pubis and through the abdominal wall
and is tightened. The mesh ends are cut at the abdominal wall, and
the mesh is left implanted in the body. This trans-vaginal
procedure is exemplified by the TVT product sold by Ethicon Inc., a
Johnson & Johnson Company, of Somerville, N.J., USA. In this
procedure two 5 mm needles pass a PROLENE mesh trans-vaginally and
through the abdomen to create a tension-free support under the
mid-urethra.
Sub-urethral slings have also been placed by a different approach
wherein a needle is passed first though the abdominal wall along
the same path as described above, and eventually exiting through
the vaginal incision. The tape is then coupled to the needle in
some manner, and pulled back through the body from the vaginal
incision and out through the abdominal incision. The chosen
approach, vaginal or abdominal, will often depend on the
preferences of the surgeon.
Yet another approach for implanting a sub-urethral sling has also
been recently developed in which the implanted sling extends from
beneath the urethra, and out through the obturator hole on either
side. This "transobturator" procedure may involve inserting an
appropriately configured needle from a vaginal incision and
subsequently out through the obturator hole, or vice versa. The
former technique (an "inside-out" approach) and associated
instruments are described in detail in U.S. Pat. Nos. 7,611,454,
7,204,802, and 7,261,723, and U.S. Patent Publication No.
2009/0306459, which are incorporated herein by reference in their
entirety. As illustrated in U.S. Pat. No. 7,261,723, this technique
may be performed using a surgical instrument including a surgical
passer or introducer and tube elements applied over the ends of the
surgical passers that are coupled to the tape to be implanted under
the urethra.
More recently, sub-urethral slings that do not exit the body
through the abdominal wall or the buttocks have been developed.
These sub-urethral slings, sometimes referred to as "mini slings,"
are shorter in length and have ends that are secured inside the
body into bone, tissue or the like. One embodiment of a "mini
sling" is described in U.S. Pat. No. 7,285,086, the disclosure of
which is hereby incorporated by reference herein.
With "mini slings" of this type, proper and accurate positioning of
the distal ends within targeted tissue is essential in order to
have and maintain the proper amount of support under the urethra to
alleviate incontinence. One problem encountered in achieving this
is that the ends of the sling must be coupled to some type of
insertion device to be placed in position, then subsequently
uncoupled from the insertion device so that the insertion device
can be withdrawn leaving the implant in place within the body.
Known insertion devices for coupling an implant to the insertion
device, however, have no attachment mechanisms, have cumbersome
attachment mechanisms, and/or require undesirable forces to be
applied to uncouple the implant, which, in turn, frequently moves
or dislodges the ends of the implant from the targeted and desired
position upon uncoupling.
Thus, it would be desirable to provide an improved implant
insertion system and surgical insertion devices that minimize or
eliminate movement of the implant upon uncoupling of the implant
from the insertion device.
SUMMARY OF THE INVENTION
In one embodiment, the present application discloses an implant
insertion system including an insertion device having proximal and
distal ends, an implant, and one or more insertion tips attached to
the implant for advancing the implant through tissue and holding
the implant at a desired location within the tissue. In one
embodiment, the one or more insertion tips have distal ends that
are pointed and proximal ends that are attached to the implant. In
one embodiment, a proximal end of an insertion tip is secured with
the distal end of the insertion device by placing the insertion tip
over the distal end of the insertion device and moving the
insertion tip in a proximal direction. The insertion tip is
desirably secured to the distal end of the insertion device without
elastically displacing any part of the insertion tip. The insertion
device, with the insertion tip locked to the distal end thereof, is
used for advancing the insertion tip and the implant attached to
the insertion tip through tissue. After the insertion tip is
positioned at a desired location within the tissue, the insertion
tip is unlocked from the distal end of the insertion device without
altering the position of the insertion tip or elastically
displacing the insertion tip.
In one embodiment, an implant insertion system preferably includes
an implant, and at least one insertion tip secured to the implant,
each insertion tip having a distal end, a proximal end, a tapered
point at the distal end, a base extending proximally from the
tapered point, and a central lumen formed in the base having an
opening facing the proximal end of the insertion tip. The system
preferably includes an insertion device having an outer shaft and a
latching assembly provided at a distal end of the outer shaft that
is insertable into the opening of the central lumen for selectively
locking the insertion tip to the latching assembly. The latching
assembly has an outer dimension that is changeable from an expanded
state for locking the insertion tip to the latching assembly to a
non-expanded state for unlocking the insertion tip from the
latching assembly.
In one embodiment, when the latching assembly is in the expanded
state, the outer dimension of the latching assembly is greater than
an inner dimension of the central lumen of the insertion tip for
locking the insertion tip to the latching assembly. When the
latching assembly is in the non-expanded state, the outer dimension
of the latching assembly is less than or approximately equal to the
inner dimension of the central lumen of the insertion tip for
unlocking the insertion tip from the latching assembly. In one
embodiment, the latching assembly, when in the non-expanded state,
may form a slight interference fit with the inner dimension of the
central lumen.
In one embodiment, the central lumen of the insertion tip has a
width, whereby the latching assembly is wider than the width of the
central lumen when the latching assembly is in the expanded state
and narrower than or approximately equal to the width of the
central lumen when the latching assembly is in the non-expanded
state.
In one embodiment, the latching assembly has a proximal end
attached to the distal end of the outer shaft, a distal end, a
central opening extending between the proximal end and the distal
end of the latching assembly, and first and second latches at the
distal end of the latching assembly. The first and second latches
preferably have respective first and second latch posts that
project away from one another.
In one embodiment, one or more windows or fenestrations are formed
in the base of the insertion tip. In one embodiment, first and
second windows are desirably formed in opposing side walls of the
base. The first and second windows preferably oppose one another,
and intersect with the central lumen formed in the base of the
insertion tip.
In one embodiment, the first and second latches are further apart
from one another when the latching assembly is in the expanded
state and are closer together when the latching assembly is in the
non-expanded state. In one embodiment, the first and second latches
are elastic and normally flex inwardly toward one another.
In one embodiment, when the latching assembly is in the expanded
state, the first and second latch posts extend into the first and
second windows in the base of the insertion tip for locking the
insertion tip to the latching assembly.
In one embodiment, the system includes a tip pin disposed within
the central opening of the latching assembly. The tip pin is
desirably made of metal and is free to slide distally and
proximally within the central opening of the latching assembly.
In one embodiment, the tip pin has a proximal end, a distal end, a
shaft extending between the proximal and distal ends, a reduced
diameter neck formed in the shaft, and an annular base at the
proximal end of the tip pin. In one embodiment, the shaft has a
first diameter, the reduced diameter neck has a second diameter
that is smaller than the first diameter of the shaft, and the
annular base has a third diameter that is greater than the first
diameter of the shaft and greater than the diameter of the central
opening of the latching assembly.
In one embodiment, the first and second latches have inner cam
surfaces that slide over the outer surface of the tip pin shaft.
When the latching assembly is in the non-expanded state, the distal
end of the tip pin is distal to the distal end of the latching
assembly and the inner cam surfaces of the first and second latches
are in contact with the reduced diameter neck of the tip pin. When
the latching assembly is in the expanded state, the distal end of
the tip pin is aligned with the distal end of the latching assembly
and the inner cam surfaces of the first and second latches are in
contact with the first diameter section of the tip pin shaft
adjacent the distal end of the tip pin.
In one embodiment, the insertion device includes a handle having a
proximal end and a distal end with the proximal end of the outer
shaft secured to the distal end of the handle. The insertion device
desirably includes an actuator provided on the handle that is
moveable between the proximal and distal ends of the handle. The
outer shaft desirably has an elongated conduit extending between
the proximal and distal ends thereof, and a push wire is disposed
within the elongated conduit of the outer shaft, which is moveable
in distal and proximal directions relative to the outer shaft. The
push wire has a proximal end opposing the actuator and a distal end
opposing the annular base of the tip pin. The push wire is not
connected with the actuator or the tip pin, and is preferably free
to move distally and proximally within the elongated conduit of the
outer shaft. In one embodiment, the push wire may have some
resistance to movement within the elongated conduit of the outer
shaft, however, when an end of the push wire receives a force, the
push wire remains free to move in distal and proximal directions
within the outer shaft.
In one embodiment, the insertion tip is locked onto the latching
assembly by placing the central lumen of the insertion tip over the
distal end of the latching assembly and pushing the insertion tip
toward the proximal end of the latching assembly for forcing the
tip pin to move proximally, which, in turn, urges the first and
second latches away from one another. As the first and second
latches move away from one another, the latch posts advance into
the windows formed in the base of the insertion tip for locking the
insertion tip to the latching assembly.
In one embodiment, the insertion tip is unlocked from the latching
assembly by moving the actuator toward the distal end of the
handle, which, in turn, urges the push wire distally for contacting
the annular base of the tip pin, and which, in turn, urges the tip
pin distally for aligning the reduced diameter neck of the tip pin
with the inner cam surfaces of the first and second latches so that
the first and second latches are free to flex inwardly toward one
another.
In one embodiment, the central lumen of the insertion tip has a
closed end wall adjacent a distal end of the base, a top wall that
defines an upper surface of the central lumen, a bottom wall that
defines a lower surface of the central lumen, and opposing side
walls extending between the top and bottom walls of the central
lumen, whereby the first and second window openings in the base of
the insertion tip extend through the side walls of the central
lumen.
In one embodiment, the insertion tip preferably includes an
elongated flat surface that extends proximally from the bottom wall
of the central lumen to the proximal end of the insertion tip. In
one embodiment, when the latching assembly is inserted into the
central lumen, the latching assembly has a flat bottom surface that
engages the bottom wall of the central lumen and the distal end of
the outer shaft has a flat surface that engages the elongated flat
surface that extends proximally from the bottom wall of the central
lumen to the proximal end of the insertion tip. In one embodiment,
the latching assembly is centrally located at the distal end of the
outer shaft. In one embodiment, the latching assembly is not
centrally located at the distal end of the outer shaft.
In one embodiment, the insertion tip has a hoop provided under the
elongated flat surface adjacent the proximal end of the insertion
tip. The hoop has a hoop opening for receiving an end of the
implant. In one embodiment, the hoop has one or more ribs provided
inside the hoop for providing frictional engagement between the
hoop and the implant for attaching the implant to the insertion
tip. The one or more ribs may extend only partially along the
length of the hoop and not along the full length of the hoop. In
one embodiment, the hoop has lead-ins to aid in pulling the mesh
implant into the hoop. In one embodiment, a securing element is
passed through a distal end of the hoop opening for contacting the
mesh near the proximal end of the hoop opening, and the mesh is
pulled into the proximal end of the hoop opening for securing the
mesh to the hoop.
In one embodiment, the latching assembly has a flat top surface
that engages the top wall of the central lumen of the insertion tip
when the flat bottom surface of the latching assembly engages the
bottom wall of the central lumen of the insertion tip.
In one embodiment, the implant has a central section and first and
second arms extending from opposite sides of the central section. A
first insertion tip is secured to the first arm and a second
insertion tip is secured to the second arm.
In one embodiment, the system includes a first-hand insertion
device, such as a left-hand insertion device, for securing the
first insertion tip and a second-hand insertion device, such as a
right-hand insertion device, for securing the second insertion
tip.
In one embodiment, the outer shaft of the insertion device is made
of metal, the handle of the insertion device is plastic, the
actuator is plastic, the latching assembly is made of a polymer
material, a metal, or a durable material, the tip pin is made of
metal, the implant is a surgical mesh, the insertion tip is made of
a polymer such as PP or PDS, and the push wire is flexible and made
of stainless steel, polymers, nylon, Teflon, or polypropylene, or
combinations thereof.
In one embodiment, the implant insertion system is used for
treating stress urinary incontinence (SUI), whereby the implant is
used in women as a sub-urethral sling for the treatment of stress
urinary incontinence resulting from urethral hypermobility and/or
intrinsic sphincter deficiency.
In one embodiment, an implant insertion method desirably includes
providing a mesh implant having first and second insertion tips
attached to the implant, securing the first insertion tip to a
first insertion device without elastically displacing any part of
the first insertion tip, positioning the first end of the surgical
mesh implant within a patient in a first location, fixedly securing
the second insertion tip to a second insertion device without
elastically displacing any part of the second insertion tip,
positioning the second end of the surgical mesh implant within a
patient in a second location, adjusting the first and second
locations relative to each other until the desired placement of the
surgical mesh is achieved, and unlocking the first and second
insertion tips from the respective first and second insertion
devices without imparting movement of the insertion tips from their
respective first and second locations and without elastically
displacing the first and second insertion tips.
In one embodiment, the implant is a surgical mesh having an overall
length of about 6-16 cm, and more preferably about 12 cm. In one
embodiment, the surgical mesh has a central zone that is about 3 cm
long.times.1.1 cm wide, and first and second arms having lengths of
about 4.5 cm and widths of about 0.95 cm. The arms are integrally
attached to both ends of the central zone.
In one embodiment, the implant preferably includes a placement loop
secured to the central region of the implant. In one embodiment,
the placement loop is a sterile, single-patient use device
consisting of a monofilament loop of PROLENE.TM. suture with an
attached polypropylene button. The loop and the button are
pre-assembled as part of the implant at the center of the mesh to
aid in the placement of the central zone of the mesh under the
urethra.
In one embodiment, the implant is a surgical mesh, and one or more
insertion tips are attached to the mesh, such as by using
ultrasonic welding. In one embodiment, a proximal end of the
insertion tip includes a hoop having a hoop opening that enables
the mesh to be pulled therein, and that desirably entraps the mesh
within the hoop. In one embodiment, the hoop is melted so that it
conforms to the outer profile of the insertion tip. In one
embodiment, the hoop preferably has one or more crush points to
insure that the hoop arms fold inward and not outward during
welding. In one embodiment, the hoop preferably has one or more
internal ribs to ensure good bonding of the mesh to the insertion
tip without damaging the hoop.
In one embodiment, the mesh may be secured to the one or more
insertion tips using holes, glue, sewing, or insert welding. In
other embodiment, the insertion tips may include flexible
overlapping wings that form a hoop for aiding in mesh insertion.
The insertion tips may also be attached to the mesh using other
variants such as overmolding of the insertion tip to the mesh.
In one embodiment, when used with a surgical mesh, a function of
the insertion tip is to aid in the insertion and positioning of the
surgical mesh in a controlled manner. The insertion tip preferably
provides a tapered point affixed to the end of a surgical mesh to
aid with inserting the mesh into tissue. The tapered insertion tip
desirably facilitates controlled implantation of the mesh by
creating a tissue pathway without requiring the use of a scissor,
blunt dissection, or knife dissection. The insertion tip can be
pushed in or pulled out of the tissue, without being disconnected
from the insertion device, for providing a surgeon with the ability
to precisely position the mesh without causing unwanted tissue
trauma. The insertion tip preferably holds the surgical mesh in a
desired location until the insertion tip is intentionally unlocked
from an insertion device.
In one embodiment, the insertion tip has a central lumen for
securing the insertion tip to the distal end of an insertion
device. In one embodiment, the distal end of the insertion device
includes a latching assembly with elastic latches and the insertion
tip has one or more fenestrations, windows, or recesses formed in
the sides of the insertion tip that receive the elastic latches for
locking the insertion tip to the latching assembly.
In one embodiment, the insertion tip is made of an absorbable
material, such as PDS. In one embodiment, the absorbable insertion
tip will degrade in the body over a period of about three-nine
months. In one embodiment, the insertion tip is may be made of
non-absorbable materials, such as polypropylene.
In one embodiment, the insertion tip has a diameter that is
slightly greater than the diameter of the distal end of the shaft
of the insertion device. In one embodiment, the insertion tip has a
diameter of about 4 mm, and the distal end of the shaft of the
insertion device has a diameter of about 3 mm.
In one embodiment, the insertion device has a curved distal
section. In one embodiment, the distal end of the insertion device
and the proximal end of the insertion tip are designed to be
engaged in a predetermined orientation. In one embodiment, the
insertion tip has a pointer or alignment indicator that aids in
alignment of the insertion tip with respect to the insertion
device.
In one embodiment, the insertion tip preferably has a tail used to
contain the end of a mesh implant. The tail may assist in orienting
the insertion tip relative to the insertion device. In one
embodiment, the insertion device has a shaft with a curve near the
distal end of the shaft that resists flexing of the shaft as the
implant is placed. In one embodiment, the tail of the insertion tip
is aligned with the outside curvature of the curved shaft of the
insertion device.
In one embodiment, the insertion tip has a conical or semi-conical
distal geometry and a barb-less structure. This design preferably
enables the insertion tip, prior to being unlocked and released
from the insertion device, to be moved in proximal and distal
directions within tissue for positioning the insertion tip in the
tissue with minimal tissue trauma.
In one embodiment, the insertion tip has barbs and/or hooks. In one
embodiment, the barbs and/or hooks are shielded from the tissue by
structures on the insertion device while engaged with the insertion
device.
In one embodiment, the implant insertion system preferably includes
two stainless steel, curved shaft inserters with plastic inserter
handles incorporating release buttons or actuators that are
designed to deliver the implant. The inserters are provided as
left-hand and right-hand insertion device units for engaging the
two insertion tips attached to the ends of the implant.
In one embodiment, the insertion device preferably includes an
actuator, a push wire, a latching assembly and a tip pin whereby
the actuator, push wire, and tip pin are not connected together.
The absence of a permanent connection between the tip pin, the push
wire, and the actuator requires the use of less force when locking
the insertion tip onto the distal end of the insertion device.
In one embodiment, the push wire may be made from stainless steel,
but may also be made of various materials such as nylon, Teflon,
polypropylene or any combination thereof. In one embodiment, the
push wire is not attached to either the actuator or the tip pin and
is free to move in distal and proximal directions within the outer
shaft of the insertion device. The push wire moves distally when
urged to move distally by the actuator, and moves proximally when
urged to move proximally by the tip pin. In one embodiment, from a
start position, the actuator is advanced distally about 0.300'',
which, in turn, results in the push wire advancing distally about
0.060''. Thus, there is some lost motion between the distal
advancement of the actuator and the distal advancement of the push
wire, and the ratio of distal travel between the actuator and the
push wire is about 5:1. In one embodiment, the actuator has a ramp
that moves distally and proximally with the actuator, and the
handle half has a fixed flexible arm that travels over the ramp as
the actuator moves distally and proximally. The engagement of the
fixed flexible arm with the ramp creates a first detectable click
when the actuator is advanced to its most distal position
(correlating with unlocking the insertion tip from the latching
assembly), and a second detectable click when the actuator is
returned to its most proximal position for beginning another
cycle.
In one embodiment, the tip pin is a wire that is used to move the
elastic latches of the latching assembly both inwardly and
outwardly. The tip pin has a wider diameter distal end that forces
the latches outwardly, and a reduced diameter neck that is located
proximal to the wider diameter distal end that enables the latches
to flex inwardly. The tip pin is free to slide in proximal and
distal directions relative to the latching assembly. The tip pin is
not attached with the push wire, which allows the tip pin to have
very detailed machining and grinding, and which requires less force
for locking the insertion tip onto the distal end of the insertion
device.
The latching assembly is preferably a one piece design that
includes a main body with elastic, flexible latches spaced from one
another at the distal end of the latching assembly. The inner
surfaces of the latches and the outer surface of the tip pin are
designed with opposing cam surfaces for selectively locking and
unlocking the insertion tip from the insertion device. When
expanded by the tip pin, the latches lock securely into the
fenestrations of the insertion tip for locking the insertion tip to
the latching assembly and adding stiffness to the assembly of the
insertion device and the insertion tip, which is important when the
insertion tip and the latching assembly are made from soft
materials such as absorbable PDS and polycarbonate,
respectively.
In one embodiment, the latching assembly may be made of metal and
may include an elongated metal body, elongated metal latches
disposed in slots formed in the elongated metal body, the latches
having opposing inner cam surfaces and respective latch posts that
extend away from one another, and an elongated rod moveable in
proximal and distal directions that is positioned between the inner
cam surfaces of the opposing metal latches. The elongated rod has
an outer surface with a protrusion that is adapted to ride over the
opposing inner cam surfaces of the latches. In one embodiment, when
an insertion tip is positioned over a distal end of the elongated
rod and moved proximally, the protrusion on the outer surface of
the elongated rod moves proximally for contacting the inner cam
surfaces for moving the latch posts away from one another. As the
latch posts move away from one another, the latch posts advance
into windows formed on an insertion tip for locking the insertion
tip to the latching assembly. When the elongated rod is moved
distally for unlocking the insertion tip from the latching
assembly, the opposing inner cam surfaces align with a smaller
diameter section of the elongated rod so that the latch posts are
able to move inwardly toward one another for being retracted from
the windows of the insertion tip. As the elongated rod moves
distally, the distal end of the elongated rod engages the closed
end of the central lumen of the insertion tip for separating the
distal end of the latching assembly from the insertion tip, while
the insertion tip remains in place in tissue.
In one embodiment, the latching assembly design is unique because
two relatively small plastic parts (i.e. polycab for the latches
and PDS for the insertion tip) enable the two parts to be strong
enough to withstand the forces of insertion and removal. This
system differs from other stress urinary incontinence devices that
require a metal tip to facilitate placement in tissue.
In one embodiment, an insertion tip has a central lumen and one
section of a wall of the central lumen extends proximally beyond
the length of the central lumen. When the insertion tip is secured
to the insertion device, one section of the elongated wall that
extends proximally from the central lumen is preferably oriented on
the outer curvature of the distal curved section of outer shaft of
the insertion device. This orientation desirably maintains the
centrality of the insertion tip relative to the insertion device
and ensures proper alignment of the insertion tip on the distal end
of the insertion device so that a section of the elongated wall of
the insertion tip aids in resisting flexing of the insertion tip as
it is placed into tissue.
In one embodiment, the distal end of the insertion device is
designed to mate with the insertion tip such that the insertion tip
can only be mounted to the insertion device in a single
orientation. This design allows for two plastic parts (i.e., the
plastic latching assembly and the plastic insertion tip) to
cooperatively resist bending that to date has only been achieved
when using insertion tips made of metal.
In one embodiment, moving the insertion tip in a proximal direction
over the distal end of the insertion device causes proximal
movement of a tip pin, which, in turn, causes outward radial
deployment of one or more latches of the latching assembly. The
outwardly moving latches advance into fenestrations, windows or
recesses formed in the insertion tip for securing the insertion tip
to the latching assembly at the distal end of the insertion device.
In one embodiment, the proximal motion of the insertion tip to
engage the tip pin on the insertion device is between about
0.02-0.06'', and more preferably about 0.040''.
In one embodiment, unlocking the insertion tip from the distal end
of the insertion device preferably includes moving a tip pin in a
distal direction for allowing inward radial movement of the elastic
latches, which enables retraction of the latches from the
fenestrations, windows or recesses for unlocking the insertion tip
from the latching assembly of the insertion device, which, in turn,
positively moves the insertion device to a new location relative to
the insertion tip for unlocking the insertion tip from the
insertion device.
The radially extendable and retractable latches enable an insertion
tip to be securely held by an insertion device via a single motion.
As a result, the insertion tip may be used to dissect tissue and/or
be positioned within tissue without concern that the insertion tip
will prematurely separate or detach from the insertion device until
desired by the surgeon. The fenestrations, windows or recesses
within the insertion tip preferably allow for positive locking and
unlocking from the inserter, encourage tissue in-growth, and
minimize the likelihood of infection.
In one embodiment, the insertion device includes a tip pin having a
outer surface that interacts with the inner cam surfaces of the
elastic latches of a latching assembly. In one embodiment, the push
wire is made of metal or polymer materials, or a combination of
both. In one embodiment, the tip pin is moved distally by a sliding
push wire that is not connected to either the tip pin or the
actuator. When the tip pin moves proximally, a larger diameter
section of the tip pin engages the inner cam surfaces of the
elastic latches for urging the latches to move in an outward radial
direction for locking the insertion tip to the insertion device.
When the tip pin is advanced distally, a reduced diameter neck
section of the tip pin engages the inner cam surfaces of the
elastic latches to enable the latches to flex in an inward radial
direction for unlocking the insertion tip from the distal end of
the insertion device.
In one embodiment, the fenestrations, windows or recesses have
respective lengths that are greater than the length of the latch
posts on the latches. The greater lengths of the fenestrations,
windows or recesses provides sufficient clearance to allow proximal
movement of the latch posts within the insertion tip to ensure that
the insertion tip does not move distally during unlocking and
release of the insertion tip from the insertion device.
In one embodiment, the actuator is used to unlock the insertion tip
from the insertion device. In one embodiment, the actuator on the
handle is pushed distally for urging the push wire to move
distally. In turn, the distally moving push wire pushes the tip pin
in a distal direction. As the tip pin is urged to move distally by
the push wire, the reduced diameter neck of the tip pin moves into
alignment with the inner cam surfaces of the elastic latches for
allowing the latches to flex inwardly, which, in turn, enables the
latches of the latching assembly to retract from the fenestrations
on the sides of the insertion tip. In one embodiment, the
tolerances and the cam angles are very precise to ensure locking
and unlocking of the insertion tip within a very short distance of
linear movement of the tip pin of about 0.010-0.020''.
In one embodiment, the actuator has an internal mechanism, such as
a ramp, attached thereto that interacts with a fixed flexible
element inside the handle to provide a detectable click and/or
tactile feedback when the actuator is pushed to a distal-most
position for signaling that the insertion tip has been unlocked
from the insertion device. In one embodiment, the fixed flexible
element rides over the ramp as the actuator is moved distally and
proximally. In one embodiment, the fixed flexible element and the
ramp generate a first detectable click when the actuator is
advanced to a distal-most position which corresponds with unlocking
of the insertion tip, and a second detectable click when the
actuator is returned to a proximal-most position. Thus, the
insertion device generates a detectable double click during a
complete cycle of movement of the actuator.
In one embodiment, a return spring is connected with the actuator
for returning the actuator to an initial start position after the
actuator has been pushed distally. The return spring enables
multiple firing of the insertion device in the event of reloading
or test firing prior to final use.
In one embodiment, a shield is provided at the distal end of the
insertion device to protect and/or isolate the insertion tip from
tissue until the insertion device has reached a desired location.
In one embodiment, when the insertion tip and shield reach the
desired location, the shield may be retracted and or removed to
expose the insertion tip for enabling the insertion tip to be
advanced into tissue. The shield preferably acts as a tissue stop
to prevent unintended damage and/or injury to surrounding organs,
tissue, or body structures.
In one embodiment, the implant insertion system includes an
atraumatic winged guide, which is a stainless steel accessory
instrument that facilitates consistent passage of the implant
through the dissection tract. The winged guide is marked with an
insertion zone to aid the surgeon's assessment of the inserted
depth. The insertion zone indicates a distance of 3-4 cm from the
tip of the winged guide.
In one embodiment, an alternate method of fixedly attaching an
insertion tip to an insertion device uses a `snap-tip` arrangement.
In this embodiment, the central lumen of the insertion tip is
elastically deformed by a protrusion (i.e., a raised portion)
provided on the outer surface of the insertion device as the
insertion device moves in a distal direction within the central
lumen of the insertion tip. The elastic deformation of the central
lumen returns to its original shape when the protrusion on the
insertion device reaches a recess, widened section, or window
located toward the distal end of the central lumen of the insertion
tip. Alternatively, the protrusion may reside on the inside of the
central lumen of the insertion tip and the corresponding recess may
reside on an outer surface of a distal end of an insertion
device.
In one embodiment, the snap-tip arrangement has no moving parts.
The snap tip may be made of plastic, metal or other suitable
materials. The snap-tip protrusions insertable into fenestrations
have a profile size of about 0.002-0.030'' and more preferably in
the range of about 0.010''-0.020''. The protrusions on the snap tip
may be at full width to fill the fenestrations in the insertion tip
or smaller depending on the holding force that is required. The
protrusions may also include a radius at the distal end. In one
embodiment, the shape of the protrusions on the snap-tip may be
formed using a grinding machine to form a detent lock having
unlocking forces that can be altered by changes to angles and/or
diameters of the snap-tip body or the snap-tip protrusions.
These and other preferred embodiments of the present invention will
be described in more detail below.
BRIEF DESCRIPTION OF THE DRAWING
FIG. 1A shows a top plan view of an insertion device of an implant
insertion system, in accordance with one embodiment of the present
invention.
FIG. 1B shows a top plan view a left-hand insertion device and a
right-hand insertion device of an implant insertion system, in
accordance with one embodiment of the present invention.
FIG. 2A shows a top plan view of an implant having a central
region, first and second arms, first and second insertion tips
secured to the respective first and second arms, and a pull loop,
in accordance with one embodiment of the present invention.
FIG. 2B shows the implant of FIG. 2A and the left-hand and
right-hand insertion devices of FIG. 1B.
FIG. 3A shows a perspective view of an insertion tip for an
implant, in accordance with one embodiment of the present
invention.
FIG. 3B shows another perspective view of the insertion tip shown
in FIG. 3A.
FIG. 3C shows a side elevation view of the insertion tip shown in
FIGS. 3A and 3B.
FIG. 3D shows a rear elevation view of the insertion tip shown in
FIGS. 3A-3C.
FIG. 4 shows a perspective view of the first end of the implant of
FIG. 2A after mesh attachment, in accordance with one embodiment of
the present invention.
FIG. 5A shows a front elevation view of an upper half of a handle
of the insertion device of FIG. 1A, in accordance with one
embodiment of the present invention.
FIG. 5B shows a perspective view of the bottom surface of the upper
half of the handle shown in FIG. 5A, in accordance with one
embodiment of the present invention.
FIG. 5C shows a perspective view of an internal part of an actuator
including a ramp and a flexible element having a free end that
engages the ramp, in accordance with one embodiment of the present
invention.
FIGS. 6A-6C show a method of using an insertion device for
generating a detectable click, in accordance with one embodiment of
the present invention.
FIG. 7A shows a cross-sectional view of a push wire, a latching
assembly, a tip pin, and an insertion tip, in accordance with one
embodiment of the present invention.
FIG. 7B shows a magnified view of the latching assembly, tip pin,
and insertion tip shown in FIG. 7A.
FIG. 8 shows a cross-sectional view of the tip pin shown in FIGS.
7A-7B, in accordance with one embodiment of the present
invention.
FIG. 9 shows a side elevation view of the distal end of the
insertion device shown in FIG. 1A.
FIG. 10 shows a bottom plan view of the distal end of the insertion
device shown in FIG. 9.
FIGS. 11A-11B shows the distal end of an insertion device with a
latching assembly moving between a non-expanded state and an
expanded state, in accordance with one embodiment of the present
invention.
FIGS. 12A-12C show a method of self-locking and securing an
insertion tip of an implant to a latching assembly at a distal end
of an insertion device, in accordance with one embodiment of the
present invention.
FIGS. 13A-13C show a method of attaching an insertion tip to a
latching assembly of an insertion device, in accordance with one
embodiment of the present invention.
FIGS. 14A-14C show a cross-sectional view of a method of securing
and self-locking an insertion tip to a latching assembly at a
distal end of an insertion device, in accordance with one
embodiment of the present invention.
FIGS. 14D-14F show a cross-sectional view of a method of unlocking
an insertion tip from a latching assembly at a distal end of an
insertion device, in accordance with one embodiment of the present
invention.
FIGS. 15A-15Y show a method of using an implant insertion system
for treating a patient, in accordance with one embodiment of the
present invention.
FIG. 16 shows a perspective view of a distal end of an insertion
device having a protective shroud that surrounds an insertion tip
for an implant, in accordance with one embodiment of the present
invention.
FIG. 17A shows a perspective view of a ground distal end of an
insertion device for an implant, in accordance with one embodiment
of the present invention.
FIG. 17B shows a left side elevation view of the ground distal end
of the insertion device shown in FIG. 17A.
FIG. 18A shows a perspective view of a turned/machined distal end
of an insertion device for an implant, in accordance with one
embodiment of the present invention.
FIG. 18B shows a left side elevation view of the distal end of the
insertion device shown in FIG. 18A.
FIG. 18C shows a distal end of the insertion device shown in FIGS.
18A and 18B, in accordance with one embodiment of the present
invention.
FIG. 19 shows an implant having a central mesh region, first and
second suture loops secured to the central mesh region, first and
second insertion tips secured to the respective first and second
suture loops, and a pull loop, in accordance with one embodiment of
the present invention.
DETAILED DESCRIPTION
Referring to FIG. 1A, in one embodiment, an implant insertion
system preferably includes an insertion device 20, having a handle
22 with a proximal end 24 and a distal end 26. The insertion device
20 includes an outer shaft 28 having a proximal end 30 secured to
the handle 22 and a distal end 32 remote therefrom. The distal end
32 of the outer shaft 28 is a free end of the outer shaft and is
adapted for connection with an insertion tip of an implant
insertion tip, as will be described in more detail herein. The
outer shaft 28 preferably includes a midsection 34 located between
the proximal end 30 and the distal end 32 thereof. The outer shaft
28 has a first section 36 extending between the proximal end 30 and
the midsection 34 that is substantially straight, and a second
section 38 extending between the midsection 34 and the distal end
32 that is curved. In one embodiment, the distal-most end 32 of the
outer shaft 28 is preferably straight. The insertion device 20
includes an actuator 40 that is slideable toward the distal end 26
of the handle 22 for selectively unlocking and/or releasing an
insertion tip secured to the distal end 32 of the outer shaft
28.
In one embodiment, the distal end 26 of the handle 22 preferably
includes first and second flat surfaces 25A, 25B that are separated
by a dividing line 27. The first and second flat surfaces 25A, 25B
are adapted for being engaged by a surgeon's thumb for enabling the
surgeon to have more leverage and control over the insertion device
20 during a surgical procedure.
Referring to FIG. 1B, in one embodiment, the implant insertion
system preferably includes a left-hand insertion device 20A, which
is similar to the insertion device 20 shown in FIG. 1A, and a
right-hand insertion device 20B. The left-hand insertion device 20A
and the right-hand insertion device 20B are preferably mirror
images of one another. The second section 38A of the outer shaft
28A of the left-hand insertion device 20A curves to the left and
the second section 38B of the outer shaft 28B of the right-hand
insertion device 20B curves to the right. The left-hand and
right-hand insertion devices 20A, 20B preferably operate in a
similar manner with one difference being that the outer shaft 28A
on the left-hand device 20A curves to the left and the outer shaft
28B on the right-hand device 20B curves to the right. In one
embodiment, the outer shaft 28A of the left-hand insertion device
20A preferably curves to the left from the perspective of a
surgeon, which is toward the right-hand side of a patient, and the
outer shaft 28B of the right-hand insertion device 20B preferably
curves to the right from the perspective of the surgeon, which is
toward the left-hand side of the patient.
Referring to FIG. 2A, in one embodiment, the left and right-hand
insertion devices 20A, 20B shown in FIG. 1B may be utilized for
securing an implant 42 to tissue. The implant 42 may be made of a
mesh material. In one embodiment, the implant 42 has a length
L.sub.1 of about 8-20 cm, and more preferably about 12 cm. The
implant 42 has a central region 44 having a length L.sub.2 of about
2-4 cm and more preferably about 3 cm, and a width W.sub.1 of about
0.8-1.5 cm and more preferably about 1.1 cm. The implant 42
includes first and second arms 46, 48 that are integrally formed
with and extend from opposite ends of the central region 44. The
first and second arms have a length L.sub.3 of about 3-5 cm and
more preferably about 4.5 cm, and a width W.sub.2 of about 0.5-1.2
cm and more preferably about 0.95 cm. The implant 42 desirably
includes a first insertion tip 50A that is attached to the outer
end of the first arm 46 of the implant 42, and a second insertion
tip 50B that is attached to the outer end of the second arm 48 of
the implant 42. The insertion tips 50A, 50B are preferably used for
advancing the implant 42 through tissue and for securing the
implant at a desired location within the tissue.
In one embodiment, the insertion tips 50A, 50B have an outer
diameter OD.sub.1 of about 3-5 mm, and more preferably about 4 mm.
In one embodiment, the width W.sub.2 of the first and second arms
46, 48 of the implant 42 is less than the width W.sub.1 of the
central region 44 of the implant so that the first and second arms
46, 48 are less resistant to lengthening than is the central region
44. The reduced resistance to lengthening preferably reduces the
footprint of the arms as they are advanced through a surgical
opening and into tissue. Although the present invention is not
limited to any particular theory of operation, it is believed that
the smaller relative width of the first and second arms 46, 48,
which enables more stretching of the arms than the central section
when under tension, which provides an implant 42 having
auto-tensioning capabilities.
In one embodiment, the mesh material is preferably made of
polypropylene, or a combination of polypropylene and MONOCRYL
absorbable material. In one embodiment, the implant preferably
includes a mesh, such as a shaped piece of blue (phthalocyanine
blue, color index number 74160) PROLENE.TM. polypropylene mesh. The
implant is attached to two insertion tips such as violet (D&C
violet no. 2, color index number 60725) PDS.TM. (Polydioxanone)
absorbable insertion tips. The absorbable insertion tips are
preferably molded from polydioxanone identical in composition to
that used in PDS.TM. II (polydioxanone) suture.
In one embodiment, the mesh is preferably constructed of knitted
monofilaments of extruded non-absorbable polypropylene strands
identical in composition to polypropylene suture sold under the
trademark PROLENE.TM.. The PROLENE.TM. mesh is knitted using a
process that interlinks each fiber junction and provides elasticity
that allows adaptation to various stresses encountered in the
body.
In one embodiment, the implant 42 is a sterile device that is
intended to be used one time on a single patient. In one
embodiment, the implant preferably includes a placement loop 51
with a button secured to the central region 44 of the implant. In
one embodiment, the placement loop has a monofilament loop of
PROLENE.TM. suture with an attached polypropylene button. The loop
and the button are pre-assembled as part of the implant at the
center of the mesh to aid in the placement of the central region 44
of the mesh under an urethra.
Referring to FIG. 2B, in one embodiment, the left-hand insertion
device 20A has an outer shaft 28A with a curved section 38A that
curves to the left, which is adapted for securing the first
insertion tip 50A to a latching assembly at the distal end of the
outer shaft 28A. The right-hand insertion device 20B includes an
outer shaft 28B having a curved section 38B that curves to the
right, which is adapted for securing the second insertion tip 50B
to a latching assembly at the distal end of the outer shaft
28B.
In one embodiment, the first insertion tip 50A is secured to the
distal end 32A of the outer shaft 28A of the left-hand insertion
device, and the distal end of the left-hand insertion device 20A is
utilized for positioning the first arm 46 of the implant 42 within
a patient at a first location. The second insertion tip 50B is
secured to the distal end 32B of the outer shaft 28B of the
right-hand insertion device 20B, and the right-hand insertion
device 20B is utilized for positioning the second arm 48 of the
implant 42 within a patient at a second location. The left and
right-hand insertion devices 20A, 20B may be utilized for adjusting
the spacing between the first insertion tip 50A and the second
insertion tip 50B until the implant 42, including the central
region 44 of the implant, has been positioned at a desired
location.
When the insertion tips 50A, 50B and the implant 42 have been
properly positioned within a patient, the actuators 40A, 40B on the
respective left and right-hand insertion devices 20A, 20B are
utilized for unlocking the first and second insertion tips 50A, 50B
from the latching assemblies at the distal ends of the respective
left and right-hand insertion devices 20A, 20B. As will be
described in greater detail herein, once the insertion tips have
been positioned at desired locations, the first and second
insertion tips 50A, 50B are desirably unlocked and released from
the distal ends of the respective left and right-hand insertion
devices without moving the first and second insertion tips from
their respective desired locations.
Referring to FIGS. 3A-3C, in one embodiment, an insertion tip 50
for an implant preferably includes a proximal end 52 and a distal
end 54 having a tapered point 56. The insertion tip 50 includes a
base 58 that extends proximally from the tapered point 56. The
insertion tip 50 has a central lumen 60 that is surrounded by the
base 58. The central lumen 60 desirably has a distal end that is
closed and a proximal end that is open for receiving the latching
assembly at the distal end of an insertion device (FIG. 2B). A pair
of opposing fenestrations or windows 62A, 62B are formed in the
sides of the base 58 and provide radial access into the central
lumen 60.
The insertion tip 50 preferably includes an elongated flat surface
64 that extends proximally from the central lumen 60 toward the
proximal end 52 of the insertion tip 50. The elongated flat surface
64 has a distal end that is co-planar with a bottom wall or floor
of the central lumen 60. The bottom wall or floor of the central
lumen 60 intersects with lower ends of the opposing windows 62A,
62B.
The insertion tip 50 desirably includes a sloping surface 66 at the
proximal end 66 of the insertion tip 50 that slopes in a downward
and proximal direction between the elongated flat surface 64 and
the proximal end 52 of the insertion tip 50. The sloping surface 66
preferably engages an opposing sloping surface provided at a distal
end of an outer shaft of an insertion device as will be described
in more detail herein.
The insertion tip 50 desirably extends along a longitudinal axis
A.sub.1. In one embodiment, the insertion tip 50 includes an
alignment post 68 that also extends along the longitudinal axis
A.sub.1. The alignment post 68 preferably enables surgical
personnel to properly orient the insertion tip 50 relative to the
distal end of an insertion device. The alignment post 68 may also
enable surgical personnel to properly orient the insertion tip 50
within a patient's body.
Referring to FIGS. 3B and 3D, the insertion tip 50 preferably
includes a hoop 70 adapted to capture an end of the implant 42
(FIG. 2A). The hoop 70 preferably includes a first side wall 72
having a first crush point 74 and a second side wall 76 having a
second crush point 78. The hoop 70 desirably includes a base 80
that spans the gap between the first side wall 72 and the second
side wall 76. The first and second side walls 72, 76 and the base
80 desirably define a hoop opening 82 adapted to receive an end of
an implant. In one embodiment, the base 80 desirably has an
internal rib 84 that extends along the longitudinal axis A.sub.1 of
the insertion tip 50. The rib 84 may extend only partially along
the length of the hoop 70. The rib 84 desirably provides frictional
engagement with the implant when the hoop 70 is collapsed onto the
end of the implant inserted into the hoop opening 82.
In one embodiment, an end of an implant, such as the end of a mesh
implant, is pulled into the hoop opening 82 via a hook placed
through the distal end of the hoop opening. In one embodiment, the
hoop is crushed down and the crush points 74, 78 in the first and
second side walls 72, 76 are pushed inwardly toward one another for
collapsing the hoop opening 82 so that the end of the implant is
pinched between the first and second side walls 72, 76 and the hoop
base 80. The internal rib 84 desirably forms a frictional
engagement with the implant material inserted into the hoop opening
for holding the implant material within the hoop opening 82. The
hoop is preferably melted to the bottom of the elongated flat
surface to capture the end of the mesh within the collapsed
hoop.
Referring FIGS. 3C and 3D, in one embodiment, the central lumen 60
of the insertion tip 50 is defined a bottom wall 85, a top wall 86
that opposes the bottom wall 85, and internal, opposing side walls
88A, 88B. The elongated flat surface 64 is co-planar with and
extends proximally from the bottom wall 85. In one embodiment, the
bottom wall 85, the top wall 86 and the internal, opposing side
walls 88A, 88B define a parallelogram, such as a square or
rectangular shaped opening. The distal-most end of the insertion
device 20 (FIG. 1) preferably includes a latching assembly having a
square or rectangular shaped tip that matches the square or
rectangular shaped opening of the central lumen 60.
Referring to FIGS. 3C and 3D, in one embodiment, the insertion tip
50 extends along the longitudinal axis A.sub.1. The elongated flat
surface 64 lies within a horizontal plane HP, and the alignment
post 68 and the internal rib 84 lie within a vertical plane VP. The
horizontal plane HP is desirably perpendicular to the vertical
plane VP.
Referring to FIGS. 2A, 3D and 4, in one embodiment, a free end of
the first arm 46 of the implant 42 is attached to the hoop opening
82 at the proximal end 52 of the first insertion tip 50A. In one
embodiment, the hoop is collapsed and the first and second side
walls 72, 76 of the hoop 70 are collapsed inwardly for pinching the
free end of the first arm 46 of the implant 42 between the first
and second side walls 72, 76 and the hoop base 80 for attaching the
first arm 46 of the implant 42 to the proximal end 52 of the first
insertion tip 50A. In one embodiment, the free end of the second
arm 48 (FIG. 2A) of the implant 42 is attached to the second
insertion tip 50B using the same methodology described above for
the first insertion tip 50A.
Referring to FIG. 5A, in one embodiment, the handle 22 of the
insertion device 20 (FIG. 1A) preferably includes the proximal end
24 and the distal end 26. In FIG. 5A, the lower half of the handle
22 has been removed for providing a clear view of the internal
components of the handle. The handle 22 includes the actuator 40
mounted thereon, which is adapted to slide between the proximal end
24 and distal end 26 of the handle 22. The actuator 40 desirably
includes an external part 90 that is engageable outside the handle
22 (e.g. with a thumb) and an internal part 92 that is located
inside the handle 22. The external part 90 and the internal part 92
move together along the longitudinal axis designated A.sub.1. The
internal part 92 includes a leading face 94 that extends along an
axis Y.sub.1 that is perpendicular to the longitudinal axis A.sub.1
of the insertion device 20. The internal part 92 also includes a
ramp (not shown) and an attachment post 96 that extends below the
leading face 94.
The insertion device also preferably includes an actuator return
spring 98 having a proximal end 100 connected to a post 102
provided inside the upper half of the handle 22. The actuator
return spring 98 desirably includes a distal end 104 that is
secured to the attachment post 96 provided on the internal element
92 of the actuator 40.
In one embodiment, a surgeon may engage the external part 90 of the
actuator 40 for pushing the actuator 40 toward the distal end 26 of
the handle 22 for unlocking an insertion tip from the latching
assembly at the distal end of the insertion device. As the actuator
40 moves toward the distal end 26 of the handle, the actuator
return spring 98 is stretched. When the actuator 40 is released,
the stretched spring 98, having potential energy stored therein,
returns the actuator 40 to the initial position shown in FIG.
1A.
Referring to FIGS. 5A and 5B, in one embodiment, the proximal end
30 of the outer shaft 28 is secured with the distal end 26 of the
handle 22. The outer shaft 28 preferably includes a central conduit
(not shown) that extends between the proximal end 30 of the outer
shaft 28 and the distal end 32 (FIG. 1A) of the outer shaft. The
insertion device 20 preferably includes a push wire 106 that is
disposed within the central lumen of the outer shaft 28. The push
wire 106 preferably includes a proximal end 108 that is accessible
inside the handle 22 for being contacted by the leading face 94 and
a distal end that is located adjacent the distal end of the outer
shaft 28. The push wire 106 moves freely in proximal and distal
directions within the central lumen of the outer shaft 28.
Referring to FIGS. 5A and 5B, in one embodiment, the proximal end
108 of the push wire 106 is aligned with the leading face 94 of the
internal part 92 of the actuator 40. The push wire 106 extends
through the outer shaft toward the distal end of the outer shaft
28. The actuator return spring has a proximal end 100 secured to
the post 102, and a distal end 104 secured to an anchor post 96
connected with the actuator 40. As the actuator 40 moves distally,
the actuator return spring 98 is stretched for storing potential
energy therein.
In one embodiment, the actuator 40 is pushed toward the distal end
26 of the handle 28, which simultaneously slides the leading face
94 of the internal actuator part 92 toward the distal end 26 of the
handle 22. In one embodiment, as the actuator 40 moves distally and
after lost motion, the leading face 94 of the internal actuator
part 92 ultimately abuts against the distal end 108 of the push
wire 106 for urging the push wire 106 toward the distal end of the
outer shaft 28. In one embodiment, the ratio of distal movement of
the actuator 40 to the push wire 106 is 5:1, which is due to the
lost motion between the movement of the actuator and the movement
of the push wire. A surgeon may confirm that the actuator 40 and
the leading face 94 have been fully advanced toward the distal end
26 of the handle 22 upon hearing a detectable click or receiving
tactile feedback generated by the ramp on the internal actuator
part 92 engaging a flexible element 110 located inside the handle
22. After the actuator 40 has been fully advanced in the distal
direction for unlocking the insertion tip, surgical personnel may
release the external part 90 of the actuator, whereupon the return
spring 98 pulls the actuator 40 back toward the initial start
position (shown in FIG. 5A) for resetting the arm of the flexible
element 110 on the ramp of the internal actuator part 92.
Referring to FIG. 5C, in one embodiment, as the actuator moves
distally and proximally, the flexible element 110 has a free end
111 that slides over and under the ramp 95 of the internal actuator
part 92 for generating a first detectable click when the actuator
40 is in a distal-most position and a second detectable click when
the actuator 40 is in a proximal-most position. The ramp 95
preferably includes a top surface 97 and a bottom surface 99 that
define a racetrack pattern, whereby the free end 111 of the
flexible element 110 travels around the racetrack pattern as the
actuator moves distally and proximally. In one embodiment, the top
and bottom surfaces 97, 99 of the ramp 95 slope upwardly toward the
distal end of the handle 22. In one embodiment, the flexible
element 110 is flexed up as the free end 111 slides over the top
surface 97 of the ramp 95, and the flexible element 110 is flexed
down as the free end 111 slides over the bottom surface 99 of the
ramp 95.
Referring to FIG. 6A, in one embodiment, when the actuator 40 is
retracted to a proximal-most position, the free end 111 of the
flexible element 110 is distal to a distal end of the ramp 95 and
the flexible element 110 is in an undeflected state. In FIG. 6B, as
the actuator 40 is moved distally for unlocking an insertion tip
from the latching assembly, the free end 111 of the flexible
element 110 slides over the top surface 97 of the ramp 95 for
deflecting the flexible element 110 upwardly. Referring to FIG. 6C,
when the free end 111 of the flexible element 110 clears the
proximal end of the ramp 95, the flexible element 110 snaps back to
an undeflected state for generating a first detectable click that
indicates unlocking and release of the insertion tip. In FIG. 6C,
the actuator 40 is in a distal-most position that coincides with
the unlocking of an insertion tip from the latching assembly at the
distal end of the insertion device. In one embodiment, after the
insertion tip has been unlocked from the insertion device, the
actuator 40 may be released by the surgeon whereupon the actuator
return spring pulls the actuator in a proximal direction. As the
actuator is pulled proximally, the free end 111 of the flexible
element 110 slides over the bottom surface 99 of the ramp 95 for
flexing the flexible element 110 downwardly. When the free end 111
of the flexible element 110 clears the distal end of the ramp 95,
the flexible element 110 snaps back to an undeflected state (FIG.
6A) for generating a second detectable click indicating that the
actuator 40 has returned to a proximal-most position.
Referring to FIG. 7A, in one embodiment, the insertion device
includes the push wire 106 (FIG. 5A) having a proximal end 108 and
a distal end 112. Although not shown in FIG. 7A, the push wire 106
preferably extends through an elongated conduit formed in the outer
shaft 28 of the insertion device 20 (FIG. 5B). The push wire 106 is
desirably flexible for conforming to the shape of the outer shaft.
Referring to FIG. 7B, in one embodiment, the insertion device
preferably includes a tip pin 114 that is provided at the distal
end of the outer shaft 28. The tip pin 114 desirably includes a
proximal end 116 and a distal end 118.
Referring to FIG. 8, in one embodiment, the tip pin 114 preferably
has an elongated shaft 120 having a distal end with an outer
diameter D.sub.1 of about 0.038''+/-0.001''. The tip pin 114 has a
reduced diameter neck 122 that is closer to the distal end 118 of
the tip pin than the proximal end 116 thereof. The reduced diameter
neck 122 has an outer diameter D.sub.2 of about 0.024''+/-0.001'',
which is smaller than the outer diameter D.sub.1. The proximal end
116 of the tip pin 114 has an outer diameter D.sub.3 of about
0.036''+/-0.001''. The tip pin 114 has an annular base 124 secured
to the proximal end of the elongated shaft 120 having an outer
diameter D.sub.4 of about 0.050''+/-0.002'' that is greater than
the diameter D.sub.3. In one embodiment, the tip pin 114 desirably
has a work zone designated WZ having a length L.sub.4 of about
0.010-0.020'' and more preferably about 0.015''. The work zone WZ
includes a radial surface that slopes inwardly between the section
of the tip pin having the outer diameter D.sub.1 and the section of
the tip pin having the outer diameter OD.sub.2. The inner cam
surfaces of the latches ride over the work zone WZ of the tip pin
as the tip pin moves proximally and distally for moving the latches
between a non-expanded state and an expanded state for unlocking
and locking the insertion tip with a flexible latching assembly. In
one embodiment, the tip pin moves axially about 0.015'' for moving
the latches between the non-expanded state and the expanded
state.
Referring back to FIGS. 7A and 7B, the insertion device includes a
flexible latching assembly 130 provided at the distal end of the
outer shaft 28 (FIG. 1A). The flexible latching assembly 130
includes a first elastic latch 132 and a second elastic latch 134.
The latches 132, 134 normally spring toward one another. Referring
to FIG. 7B, in one embodiment, the flexible latching assembly 130
desirably includes a central conduit 136 adapted to receive the tip
pin 114. The central conduit 136 has an inner diameter ID.sub.1 of
about 0.041''+/-0.002'' that is equal to or greater than the outer
diameters D.sub.1 and D.sub.3 at the respective distal and proximal
ends of the tip pin 114. The outer diameter D.sub.4 of the annular
base 124 of the tip pin 114 is about 0.050''+/-0.002'', which is
greater than the inner diameter ID.sub.1 of the central conduit 136
for halting distal movement of the tip pin 114 relative to the
latching assembly once the annular base 124 of the tip pin abuts
against the proximal end of the latching assembly 130. The first
elastic latch 132 has an outwardly extending latch post 138 and an
inner cam surface 140, and the second elastic latch 134 has an
outwardly extending latch post 144 and an inner cam surface
146.
Referring to FIG. 7B, in one embodiment, an insertion tip 50 is
pushed onto a distal end of the latching assembly 130 for moving
the tip pin 114 in a proximal direction designated P. As the tip
pin 114 moves proximally, the outer surface of the tip pin shaft
120, which is distal to the reduced diameter neck 122, engages the
respective inner cam surfaces 140, 146 of the first and second
latches 132, 134 for pushing the first and second latches 132, 134
away from one another. As the first and second latches 132, 134
flex away from one another, the latch posts 138, 144 are pushed
into the opposing windows 62A, 62B of the insertion tip 50 for
securing the insertion tip 50 to the latching assembly 130 at the
distal end of the insertion device. In the position shown in FIG.
7B, the inner cam surfaces 140, 146 of the latches are in contact
with the outer diameter D.sub.1 at the distal end of the tip pin
114 (FIG. 8). The retracted tip pin 114 holds the latch posts 138,
144 in the extended position so that insertion tip 50 remains
locked or secured to the distal end of the insertion device.
Referring to FIG. 7B, in one embodiment, the base 58 of the
insertion tip 50 has a blind pocket 119 with a closed end wall. The
blind pocket 119 is preferably located at a distal end of the
central lumen and is distal to the opposing windows 62A, 62B. In
one embodiment, the blind pocket 119 has a depth of about
0.010-0.030'' and more preferably about 0.020''. When the insertion
tip 50 is locked onto the end of the latching assembly 130, the
latches 132, 134 have latch extensions at distal ends thereof that
extend into the blind pocket 119 for providing lateral
stabilization of the insertion tip on the latching assembly.
In one embodiment, the opposing windows 62A, 62B have a length,
extending along the longitudinal axis of the insertion tip 50, of
about 0.030-0.070'' and more preferably about 0.050''. The latch
posts 138, 144 of the respective first and second latches
preferably have a length, extending along the longitudinal axis of
the insertion tip 50, of about 0.025-0.030'' and more preferably
about 0.028''. The lengths of the windows 62A, 62B are preferably
longer than the lengths of the respective latch posts 138, 144 so
that the latch posts can move axially relative to the windows while
being retracted, which prevents any jamming between the latching
assembly and the insertion tip. In one embodiment, the latch
extensions desirably have a length of about 0.015-0.020'', and more
preferably about 0.019''.
Referring to FIG. 9, in one embodiment, the outer shaft 28 has a
curved section 38 that is proximal to the distal end 32 of the
outer shaft. In one embodiment, the distal-most end of the outer
shaft 28 (i.e. a section that is distal to the curved section 38)
is straight. The flexible latching assembly 130 is disposed at the
distal end 32 of the outer shaft 28. In one embodiment, the
flexible latching assembly 130 includes a flat top surface 160 that
is adapted to engage the top wall 86 of the central lumen 60 of the
insertion tip 50 (FIG. 3D) and a flat bottom surface 162 that
engages the bottom wall 85 of the central lumen 60 (FIG. 4). The
distal-most end of the outer shaft 28 also includes a supplemental
flat surface 164 that is generally co-planar with the flat bottom
surface 162 of the latching assembly 130. When an insertion tip 50
is secured to the distal end 32 of the outer shaft 28, the
supplemental surface 164 preferably engages the elongated flat
surface 64 (FIG. 4) of the insertion tip 50 that is proximal to the
bottom wall 85 of the central lumen. Although the present invention
is not limited by any particular theory of operation, it is
believed that providing the flat top surface 160 and the flat
bottom surfaces 162, 164 properly orients the insertion tip 50
relative to the distal 32 of the outer shaft 28, and stabilizes the
insertion tip when it is locked to the distal end of the insertion
device.
Referring to FIG. 9, in one embodiment, before the insertion tip 50
(FIG. 4) is secured to the latching assembly 130, the distal end
118 of the tip pin 114 preferably projects beyond the distal end of
the latching assembly 130. When an insertion tip is placed onto the
latching assembly 130 and pushed proximally, the closed end wall of
the central lumen 60 (FIG. 4) at the proximal end of the base 58 of
the insertion tip 50 preferably abuts against the distal end 118 of
the tip pin 114 for moving the tip pin in the proximal direction
P.
In one embodiment, the outer shaft 28 has a sloping surface 166
that slopes inwardly between the outer surface of the outer shaft
28 and the supplemental flat surface 164. When an insertion tip 50
is secured to the distal end of the outer shaft 28, the sloping
surface 66 at the proximal end 52 of the insertion tip 50 (FIG. 3B)
preferably engages the sloping surface 166 on the outer shaft 28
for stabilizing the insertion tip at the distal end of the outer
shaft 28.
Referring to FIG. 10, in one embodiment, the distal end 32 of the
outer shaft 28 includes the supplemental flat bottom surface 164
and the sloping surface 166. In one embodiment, the sloping surface
166 includes a pair of crushable ribs 135A, 135B. The ribs 135A,
135B may be crushed to form a connection between the proximal end
of the latching assembly 130 and the distal end of the outer shaft
28 to ensure that there is no linear movement between the latching
assembly 130 and the distal end of the outer shaft 28. In one
embodiment, it is important that there is no linear movement
between the latching assembly 130 and the distal end of the outer
shaft 28 because any linear movement can adversely impact the
unlocking function since the cam action occurs within a very small
window having a length of about 0.010-0.020''. The crushable ribs
135A, 135B preferably take up any material flex during the assembly
process while ensuring that the reforming of the distal end of the
outer tube does not change the inner diameter ID.sub.1 of the
central conduit 136 of the flexible latching assembly 130 (FIG.
7B), or impede distal and/or proximal movement of the tip pin
114.
The push wire 106 extends through a central conduit of the outer
shaft 28 so that the distal end 112 of the push wire engages the
annular base 124 at the proximal end 116 of the tip pin 114. The
tip pin 114 has a distal end 118 that desirably projects beyond the
distal end of the latching assembly 130. The tip pin 114 desirably
includes a reduced diameter neck section 122 having a smaller
diameter than the diameter of the tip pin adjacent the distal end
118 thereof. The flexible latching assembly 130 includes the first
latch 132 projecting outwardly from a first side of the flexible
latching assembly and a second latch 134 projecting outwardly from
a second side of the flexible latching assembly. In one embodiment,
when the tip pin 114 moves in the proximal direction P, the larger
diameter section of the tip pin adjacent the distal end 118 thereof
pushes the first and second latches 132, 134 outward, away from one
another in the opposite radial directions R.sub.1, R.sub.2 for
expanding the width of the flexible latching assembly 130 at the
distal end thereof. In one embodiment, when the tip pin 114 is
pushed in a distal direction D by the push wire 106, the reduced
diameter neck 122 is advanced into alignment with the first and
second latches 132, 134, whereby the first and second latches flex
inwardly toward one another for reducing the width defined by the
first and second latches 132, 134 at the distal end of the latching
assembly 130.
The elongated conduit of the outer shaft 28 transitions to a larger
bore area 125 to ensure that the annular base 124 at the proximal
end of the tip pin does not move into the smaller diameter area of
the elongated conduit of the outer shaft 28.
Referring to FIGS. 11A and 11B, in one embodiment, the flexible
latching assembly 130 is located at the distal-most end 32 of an
outer shaft 28. The latching assembly 130 is preferably flexible
and includes a first latch 132 having a first latch post 138
projecting outwardly therefrom, and a second latch 134 having a
second latch post 144 projecting outwardly therefrom. The tip pin
114 extends through a central opening of the latching assembly 130.
The first and second latch posts preferably extend away from one
another in opposite directions. In FIG. 11A, the tip pin 114 is
fully extended so that the larger diameter distal end 118 of the
tip pin 114 extends beyond the distal-most end of the first and
second latches 132, 134. In one embodiment, the larger diameter
distal end of the tip pin 114 extends about 0.060'' beyond the
distal-most end of the first and second latches. The reduced
diameter neck section 122 of the tip pin 114 is in alignment with
inner cam surfaces of the first and second latches 132, 134,
whereby the latch posts 138, 144 are free to flex inwardly toward
one another to provide a reduced width at the distal end of the
flexible latching assembly 130.
Referring to FIG. 11B, in one embodiment, the tip pin 114 may be
pushed in a proximal direction P so that the larger diameter
section of the tip pin 114 adjacent the distal end 118 of the tip
pin 114 is in alignment with the inner cam surfaces of the first
and second latches 132, 134. In FIG. 11B, the larger diameter
section at the distal end 118 of the tip pin 114 is aligned with
the first and second latch posts 138, 144 for urging the first and
second latch posts away from one another. As a result, the
distal-most end of the flexible latching assembly 130 is wider than
as shown in FIG. 11A, and the first and second latch post 138, 144
are spaced further away from one another than in the original
position shown in FIG. 11A.
Referring to FIGS. 12A-12C, in one embodiment, an insertion tip 50A
attached to the first arm 46 of an implant 42 is securable to a
distal end 32 of an outer shaft 28 of an insertion device 20.
Referring to FIGS. 12B and 12C, before the insertion tip 50A is
pushed onto the latching assembly 130 at the distal end of the
insertion device, the tip pin 114 preferably projects beyond the
distal end of the flexible latching assembly 130. The tip pin 114
and the flexible latching assembly 130 are inserted into the
central lumen 60 (FIG. 4) of the insertion tip 50A. The flat bottom
surface 162 of the latching assembly 130 and the flat bottom
surface 164 at the distal end of the outer shaft 28 are preferably
juxtaposed with the bottom wall 85 of the central lumen 60 and the
elongated flat surface 64 of the insertion tip 50A (FIG. 4). The
first and second latch posts 138, 144 of the flexible latching
assembly 130 are preferably in alignment with the windows 62A, 62B
formed in the side wall 58 of the insertion tip 50.
In one embodiment, the insertion tip 50A is pushed in a proximal
direction P until the closed end wall of the central lumen 60 abuts
against the distal end 118 of the tip pin 114. After contact of the
end wall with the distal end 188, further movement on the insertion
tip 50A in a proximal direction results in engagement of the
insertion tip 50A with the distal end 118 of the tip pin 114 for
urging the tip pin to move in the proximal direction P. As the tip
pin 114 moves in the proximal direction P, the wider diameter
section of the tip pin 114 adjacent the distal end 118 thereof
pushes the first and second latch post 138, 144 away from one
another, whereupon the latch posts 138, 144 move into the opposing
windows 62A, 62B of the insertion tip 50A for auto-locking the
insertion tip to the latching assembly at the distal end of the
insertion device.
Referring to FIGS. 13A-13C, in one embodiment, when the insertion
tip 50A is fully inserted onto the distal end 32 of the outer shaft
28 of the insertion device, the tip pin 114 (FIG. 12C) urges the
first and second latch posts 138, 144 away from one another for
moving into the respective first and second windows 62A, 62B of the
insertion tip 50A. The first and second latch posts 138, 144 are
held in the expanded state by the tip pin 114. Referring to FIG.
13B, in one embodiment, the elongated flat surface 64 extending to
the proximal end 52 of the insertion tip 50A engages the flat
surface 164 at the outside of the outer shaft 28 for providing
rotational stability for counteracting rotational forces F.sub.1
encountered during rotational use of the insertion device. The
engagement between the elongated flat surface 64 and the flat
surface 164 prevents rotation of the insertion tip and serves as a
rotational stabilizer. Referring to FIG. 13C, in one embodiment,
latch extensions at the distal-most ends of the first and second
latches extend into the blind pocket 119 (FIG. 7B) formed in the
base 58 of the insertion tip 50A for providing lateral stability
for counteracting lateral forces F.sub.2 when the insertion tip is
locked to the latching assembly at the distal end of the insertion
device. The first and second latch posts 138, 144 will continue to
hold the insertion tip 50A onto the distal end 32 of the outer
shaft 28 until the operator of the insertion device moves the tip
pin in a distal direction so that the reduced diameter neck 122
(FIG. 8) of the tip pin 114 is once again in alignment with the
inner cam surfaces of the first and second latches 132, 134 (FIG.
12C). Once the inner cam surfaces of the first and second latches
132, 134 are returned to alignment with the reduced diameter neck
of the tip pin, the first and second latch posts 138, 144 flex
inwardly for reducing the width at the distal end of the flexible
latching assembly. At that point, the insertion tip is unlocked
from the distal end of the insertion device and the first and
second latch posts 138, 144 and the flexible latching assembly may
be retracted from the central lumen 60 (FIG. 3B) of the insertion
tip 50A.
Referring to FIG. 14A, in one embodiment, an insertion tip 50 is
pushed onto the flexible latching assembly 130 at a distal-most end
of an insertion device. Initially, the distal end 118 of the tip
pin 114 extends beyond the distal-most end of first and second
latches 132, 134. The insertion tip 50 has first and second windows
62A, 62B that are adapted to receive the respective latch posts
138, 144 on the respective first and second latches 132, 134. The
first and second latches 132, 134 have inner cam surfaces 140, 146
that are initially seated within the reduced diameter neck section
122 of the tip pin 114. The distal end 118 of the tip pin 114 and
the first and second latches 132, 134 are desirably inserted into
the central lumen 60 of the insertion tip 50 (FIG. 3B).
Referring to FIG. 14B, in one embodiment, the insertion tip 50 is
pushed in the proximal direction P until the closed end wall of the
central lumen 60 abuts against the distal end 118 of the tip pin
114 for moving the tip pin 114 in the proximal direction P. The
larger diameter section of the tip pin 114 adjacent the distal end
118 thereof engages the opposing inner cam surfaces 140, 146 of the
respective first and second latches 132, 134 for moving the latch
posts 138, 144 away from one another and advancing the latch posts
into the windows 62A, 62B of the insertion tip 50. In one
embodiment, the first and second windows 62A, 62B have an axial
length of about 0.050'', the latch posts 138, 144 have an axial
length of about 0.028'', and the latch extensions at the
distal-most ends of the latches 132, 134 have a length of about
0.019''.
Referring to FIG. 14C, in one embodiment, when the tip pin is
pushed proximally into a retracted position, the insertion tip 50
is fully seated onto the latching assembly 130 at the distal end of
the insertion device. The closed end wall of the central lumen 60
of the insertion tip 50 urges the tip pin 114 to move proximally
into the fully retracted position shown in FIG. 14C. The larger
diameter section at the distal end 118 of the tip pin 114 urges the
first and second latches 132, 134 away from one another, whereby
the first and second latch posts 138, 144 are seated within the
first and second windows 62A, 62B of the insertion tip 50 for
securing the insertion tip 50 to the distal end of the insertion
device. With the tip pin 114 is in the retracted position, the
insertion tip 50 remains locked to the distal end of the insertion
device because the latch posts 138, 144 are incapable of moving
inwardly for unlocking the insertion tip 50 from the distal end of
the insertion device. In FIG. 14C, the latch extensions at the
distal-most ends of the latches 132, 134 have a length of about
0.019'' and the blind pocket 119 seats the latch extensions for
providing lateral stability for the insertion tip. The blind pocket
119 preferably has a depth of about 0.020''. In the state shown in
FIG. 14C, the insertion device may be utilized for inserting the
insertion tip 50 and the implant into tissue at a desired location.
With the insertion tip locked to the latching assembly, the
insertion tip may also be retracted in tissue for repositioning the
insertion tip during surgery. The insertion tip 50 will remain
firmly locked to the distal-most end of the insertion device as
long as the tip pin 114 is in the retracted position shown in FIG.
14C.
Referring to FIGS. 14D-14F, in one embodiment, after the insertion
device has been used for inserting the insertion tip 50 into tissue
at a desired location, a surgeon may seek to unlock the insertion
tip from the distal end of the insertion device. In one embodiment,
a surgeon may engage the actuator 40 on the handle 22 (FIG. 5A) for
urging the push wire 106 to move in the distal direction D. After
the push wire has moved a predetermined distance, a distal-most end
112 of the push wire 106 will engage the annular base 124 at the
proximal end 116 of the tip pin 114 (FIG. 10) for moving the tip
pin 114 in the distal direction D. At this stage, the actuator
generates the detectable click and the actuator resets to the start
position. As the tip pin 114 moves distally, the distal end 118 of
the tip pin 114 provides a distal force on the closed end wall of
the central lumen 60 of the insertion tip 50, which, in turn, moves
the first and second latch posts 138, 144 in a proximal direction
so that the inner cam surfaces of the first and second latches 132,
134 are once again aligned with the reduced diameter neck 122 of
the tip pin. The first and second windows 62A, 62B have respective
lengths that are greater than the lengths of the first and second
latch posts 138, 144 so that the first and second latch posts 138,
144 may initially move proximally before they begin to move
inwardly toward one another for retracting the latch posts from the
first and second windows 62A, 62B, thereby preventing a jam
condition between the inner cam surfaces of the latches and the tip
pin. Although the present invention is not limited by any
particular theory of operation, it is believed that this structure
enables the distal end of the insertion device to be detached from
the insertion tip 50 without moving the insertion tip from the
desired location once placed in tissue.
FIG. 14E shows further proximal movement of the first and second
latches 132, 134 whereupon the opposing inner cam surfaces 140, 146
of the first and second latches move into alignment with the
reduced diameter neck 122 of the tip pin 114 so that the first and
second latch posts 138, 144 are free to flex inwardly toward one
another for being retracted from the opposing windows 62A, 62B of
the insertion tip 50.
FIG. 14F shows the inner cam surfaces 140, 146 of the first and
second latches 132, 134 fully seated within the reduced diameter
neck 122 of the tip pin 114 with the first and second latches 132,
134 fully retracted, whereby the width defined by the first and
second latch posts 138, 144 is smaller than the diameter of the
central lumen 60 of the insertion tip 50. The smaller width of the
flexible latching assembly 130 enables the distal end of the
insertion device to be removed from the central lumen 60 of the
insertion tip 50.
Referring to FIG. 15A, in one embodiment, a procedure for inserting
an implant in a patient includes placing the patient in a dorsal
lithotomy position with the legs flexed about 90.degree. and the
tip of the coccyx positioned flush with the edge of a table. The
surgical procedure may be carried out under local, regional or
general anesthesia. A urethral catheter may be inserted into the
patient's bladder for emptying the bladder prior to the
procedure.
In one embodiment, at the level of the mid urethra, a small amount
of anesthesia may be injected submucosally to create a space
between the vaginal wall and the periurethral fascia. Using a
scalpel, and starting about 1 cm proximal to the urethral meatus, a
sagittal incision of no more than 1.5 cm in length is desirably
made. The incision is preferably positioned over the mid-urethral
zone and will allow for subsequent passage of the implant.
Referring to FIG. 15B, in one embodiment, after initiating sharp
dissection, the surgeon continues to make a narrow blunt dissection
toward, but not into, the obturator membrane using pointed, curved
scissors parallel to the floor. The surgeon preferably makes left
and right periurethral incisions just into the obturator internus
muscle and behind the ischio-pubic ramus (IPR). Surgical personnel
should not dissect beyond the obturator internus muscle. The path
of the lateral dissection should preferably be in a horizontal
plane directed toward the ischio-pubic ramus in a 45.degree. angle
in relation to the coronal plane. The goal of the dissection is to
create a channel that is sufficiently wide enough for insertion of
a winged guide, as will be described in more detail below. In FIG.
15B, the horizontal plane is designated HP and the midline plane is
designated MP.
Referring to FIG. 15C, in one embodiment, an implant 42, such as
that shown and described above in FIG. 2A, is removed from a
sterile package 170 and positioned on a sterile drape or other
suitable sterile location until needed.
Referring to FIG. 15D, in one embodiment, a left-hand insertion
device 20A and a right-hand insertion device 20B are removed from
the sterile package 170 and placed upon a sterile drape or other
suitable sterile location until needed. The sterile package 170
contains a winged guide 174 that is utilized for facilitating
insertion of the implant 42 (FIG. 15C), as will be described in
more detail herein. The winged guide 174, after being removed from
the sterile package 170, is preferably placed atop a sterile drape
or other suitable sterile location until needed.
Referring to FIG. 15E, in one embodiment, the surgeon preferably
ensures proper orientation of the left-hand insertion device 20A
and the right-hand insertion device 20B. When properly oriented,
the left-hand insertion device 20A is held by the surgeon's
left-hand with the product logo and the actuator button 40A facing
toward the surgeon so that the surgeon may engage the actuator
button 40A with his/her left thumb. The distal end 32A of the outer
shaft 28A preferably extends to the left. The left-hand insertion
device 20A in the surgeon's left hand is preferably used on the
patient's right side.
The surgeon preferably orients the right-hand insertion device 20B
so that the product logo and the actuator 40B are facing toward the
surgeon so that the surgeon may engage the actuator button 40B with
his/her right thumb. The distal end 32B of the outer shaft 28B
preferably extends to the right, which is away from the distal end
32A of the outer shaft 28A of the left-hand insertion device 20A.
The right-hand insertion device 20B in the surgeon's right-hand is
preferably used on the patient's left side.
Referring to FIG. 15F, in one embodiment, the surgeon aligns the
first insertion tip 50A of the implant 42 with the flexible
latching assembly 130 at the distal end 32 of the outer shaft 28 of
the left-hand insertion device 20A. Referring to FIGS. 15F and 15G,
as the first insertion tip 50A is pushed onto the distal end of the
outer shaft 28A, the latch posts 138, 144 extend into the opposing
windows 62A, 62B of the first insertion tip 50A for attaching the
first insertion tip to the distal end 32A of the left-hand
insertion device 20A.
Referring to FIG. 15H, in one embodiment, after the left-hand
insertion device has been secured to the first insertion tip 50A of
the implant 42 (FIG. 15G), the winged guide 174 is utilized for
properly inserting the first insertion tip 50A and the first arm of
the implant into the dissected opening. In one embodiment, the
winged guide 174 preferably has an elongated shaft 176 including a
U-shaped channel 178 extending along the length thereof. The
U-shaped channel 178 preferably guides the outer shafts of the
insertion devices as they are advanced into the dissection opening.
In one embodiment, the winged guide 174 provides a correct
trajectory and path for the insertion devices through tissue to
avoid bladder and urethral injuries. The elongated shaft 176 of the
winged guide 174 has a proximal end 180 and a gripping flange 182
extending from opposite sides of the proximal end 180. In one
embodiment, the gripping flange 182 has a V-shaped configuration.
In one embodiment, the winged guide 174 includes a cut-out 183
located midway between the ends of the elongated shaft 176. The
cut-out 183 preferably defines an insertion zone along the length
of the elongated shaft 176. During a surgical procedure, the
cut-out 183 is desirably used by a surgeon to limit excessive
insertion of the elongated shaft into tissue so as to avoid
premature perforation of the obturator membrane. In one embodiment,
a surgeon will preferably halt insertion of the elongated shaft 176
when the cut-out 183 has been advanced into alignment with the
exterior surface of the surgical opening.
Referring to FIG. 15I, in one embodiment, the distal end of the
U-shaped shaft 176 of the winged guide 174 is inserted into the
dissected tract until the distal end of the shaft 176 reaches the
ischio-pubic ramus and extends slightly into the obturator internus
muscle. Preferably, surgical personnel will refer to the cut-out
183 provided on the elongated shaft 176 to halt advancement of the
winged guide 174 so that the distal end of the U-shaped shaft 176
does not perforate the obturator membrane. Advancement beyond this
preferred insertion zone may allow unintended entry into the
obturator membrane or the space of Retzius. In one embodiment, if
boney contact is not achieved after insertion of the winged guide
174 within the insertion zone, surgical personnel may preferably
remove and re-evaluate the angle of dissection. If the surgeon
encounters difficulty during insertion of the winged guide 174, the
surgeon may re-confirm the direction of the dissected tract with
scissors. The path of the winged guide 174 is desirably in a
horizontal plane, directed toward the ischio-pubic ramus in a
45.degree. angle in relation to the coronal plane.
In one embodiment, during insertion of the winged guide 174, the
obtuse or open side of the U-shaped channel 178 (FIG. 15H) of the
winged guide 174 should face the surgeon and the gripping flange
182 should be pressed tightly against the patient's contra-lateral
thigh. Referring to FIG. 15J, in one embodiment, while the surgeon
holds the winged guide 174, the distal end of the left-hand
insertion device 20A and the first insertion tip 50A connected
therewith is inserted into the dissected tract following the
U-shaped channel 178 of the winged guide 174 (FIG. 15H). The
surgeon should preferably ensure that the handle 22A of the
left-hand insertion device is oriented so that the straight section
at the distal end 32A of the outer shaft 28A is aligned with the
U-shaped channel 178 of the winged guide 174, and that the straight
section at the distal end 32A remains in that orientation until the
insertion tip reaches and/or contacts the superior border of the
inferior ischo-pubic ramus and is pushed slightly into the
obturator internus muscle, such that the insertion tip is not
advanced into the obturator membrane.
Referring to FIG. 15K, in one embodiment, after the step shown in
FIG. 15J, the surgeon removes the winged guide 174 from the
patient. The winged guide 174 is preferably maintained in a sterile
condition for later use on the patient.
In one embodiment, the handle of the insertion device is lowered
toward the table so that the handle is nearly vertical. The handle
is then moved past the patient's midline over to the contralateral
side. Using a free hand, the surgeon desirably pushes the insertion
device until the insertion tip passes through the obturator
membrane. The insertion device is then rotated while keeping the
leading edge of the inserter in contact with the ischio-pubic
ramus, stopping when the insertion tip has passed through the
obturator membrane and is positioned in the obturator externus
muscle. At this stage, the placement loop is preferably about 5 mm
before center on the patient's first insertion side. FIGS. 15L-1
and 15L-2 show the start position of the inserter handle 22A from
front and side views, respectively. FIGS. 15M-1 and 15M-2 show the
intermediate position of the inserter handle 22A from front and
side views, respectively. FIGS. 15N-1 and 15N-2 show the end
position of the inserter handle 22A from front and side views,
respectively.
Referring to FIG. 150, in one embodiment, the left-hand insertion
device 20A remains attached to the first insertion tip 50A during
the placement of the implant 42 on the patient's second side. In
one embodiment, the right-hand insertion device 20B is secured with
the second insertion tip 50B by pushing the second insertion tip
onto the latching assembly 130B at the distal end 32B of the outer
shaft 28B to form a secure connection between the distal end of the
right-hand insertion device 20B and the second insertion tip
50B.
FIG. 15P shows the second insertion tip 50B after it has been
secured to the distal end 32B of the outer shaft 28B of the second
insertion device 20B. After connection, the surgeon may ensure that
the second insertion tip 50B is securely connected by gently
pulling upon the second insertion tip. After the second insertion
tip 50B has been connected with the second insertion device 20B,
the surgeon preferably observes if the implant 42 is twisted. If
the implant is twisted, the surgeon preferably removes any twisting
to ensure that a twisted portion of the implant is not left under
the urethra.
Referring to FIG. 15Q, in one embodiment, the winged guide 174 is
inserted into the dissected tract up to the ischio-pubic ramus and
slightly into the obturator internus muscle. In one embodiment, the
advancement of the distal end of the U-shaped channel 178 of the
shaft 176 (FIG. 15H) should be stopped before the shaft 176
perforates the obturator membrane. In one embodiment, the cut-out
183 that defines the insertion zone on the winged guide 174 should
be visible during this part of the procedure. Placement of the
distal end of the winged guide 174 beyond the insertion zone may
allow unintended entry into the obturator membrane or the space of
Retzius. If boney contact is not achieved after insertion of the
winged guide 174 within the insertion zone, the surgeon should
remove and re-evaluate the angle of dissection. If the surgeon
encounters difficulty during insertion of the winged guide 174, the
surgeon should reconfirm the direction of the dissected tract with
a tool such as scissors.
Referring to FIG. 15R, in one embodiment, while the surgeon holds
the winged guide 174, the surgeon inserts the right-hand insertion
device 20B having the second insertion tip connected therewith into
the dissected tract following the U-shaped channel of the winged
guide 174 (FIG. 15H). As the distal end 32B of the outer shaft 28B
of the right-hand insertion device 20B is placed into the dissected
tract, the surgeon preferably ensures that the inserter handle 22B
is oriented so that the straight section at the distal end of the
outer shaft 28B is aligned with the U-shaped channel 178 in the
winged guide 174 (FIG. 15H) and remains in that orientation until
the second insertion tip 50B reaches and/or contacts the superior
border of the inferior ischio-pubic ramus and is pushed slightly
into the obturator internus muscle, such that the second insertion
tip 50B does not extend into the obturator membrane.
Referring to FIG. 15S, in one embodiment, after the steps shown in
FIG. 15P, the surgeon preferably removes the winged guide 174 from
the dissected opening.
Referring to FIG. 15T, in one embodiment, the surgeon preferably
rotates the handle 22B of the right-hand insertion device 20B about
its axis until the second insertion tip 50B passes through the
obturator membrane and into the obturator externus muscle while the
right-hand insertion device maintains contact with the pubic ramus.
The central zone 44 of the implant 42 is preferably positioned in
close contact to the urethra. The placement loop 51 may aid in the
exact placement of the central zone 44 of the implant 42 under the
urethra.
In one embodiment, after the first and second insertion tips 50A,
50B have been inserted into tissue at a desired location, a surgeon
may perform a cytoscopy.
Referring to FIG. 15U, in one embodiment, the second insertion tip
50B is preferably unlocked from the distal end of the right-hand
insertion device 20B by pushing the actuator 40B in a distal
direction until the surgeon hears an detectable click. As the
surgeon pushes the actuator 40B distally, the flexible latching
assembly at the distal end of the right-hand insertion device
unlocks from the second insertion tip 50B so that the outer shaft
28B of the right-hand insertion device 20B may be retracted through
the dissected opening.
In one embodiment, the left-hand insertion device 20A is unlocked
from its connection with the first insertion tip 50A and the
right-hand insertion device 20B is unlocked from its connection
with the second insertion tip 50B. In one embodiment, the surgeon
maintains a connection between one of the insertion tips and one of
the insertion devices that provides the best option for final
adjustment, if necessary.
Referring to FIG. 15V, in one embodiment, the right-hand insertion
device 20B is removed from the dissected opening by a reverse
rotation of the insertion device handle 22B. The outer shaft 28B of
the right-hand insertion device 20B preferably follows the entry
passage as it is removed from the dissected opening.
Referring to FIG. 15W, in one embodiment, the appropriate tension
provided by the implant 42 is adjusted using the left-hand
insertion device 20A. The tension may be adjusted to achieve the
desired placement for the central section 44 of the implant 42
relative to the patient's urethra. If the tension on the implant is
too high, the surgeon may gently move the first insertion tip 50A
and the mesh by pulling the mesh and slowly reversing the inserter
or by slightly retracting the left-hand insertion device. After the
proper tension level has been obtained, the surgeon preferably
unlocks the first insertion tip 50A from the distal end of the
left-hand insertion device 20A by pushing the actuator 40A in a
distal direction.
Referring to FIG. 15X, in one embodiment, after the implant 42 has
been properly positioned and appropriate tension has been applied,
the placement loop 51 may be cut to detach the loop from the
implant 42. Referring to FIG. 15Y, in one embodiment, after the
step shown in FIG. 15V, the vaginal incision is preferably
closed.
Referring to FIG. 16, in one embodiment, an insertion device for an
implant desirably includes an outer shaft 228 having a distal end
232 and a flexible or fixed latching assembly 230 provided at the
distal end of the insertion device for securing an insertion tip
250 thereto. In one embodiment, a protective shield 255 is secured
to the distal end 232 of the outer shaft 228 to isolate the tapered
point 256 of the insertion tip 250 from surrounding tissue until
the insertion tip has been advanced to a desire location inside a
body. In one embodiment, the protective shield 255 preferably
includes an elongated opening or slot 258 formed on one side
thereof for enabling the implant to be secured to the insertion tip
via the hoop 270. In one embodiment, when the insertion tip 250
secured to the distal end of the insertion device has been advanced
to a desired location, the protective shield 255 may be manually or
automatically retracted to enable the insertion tip to be
positioned in tissue at a desired location. In one embodiment, the
protective shield 255 may function as a tissue stop to prevent
injury to unintended organs or structures.
Referring to FIGS. 17A and 17B, in one embodiment, an insertion
device for an implant preferably includes a distal end having a
connector 330 adapted to form a snap-fit connection with an
insertion tip, such as the insertion tip described herein. The
connector 330 desirably includes a distal end 332 that is
insertable into a central lumen of an insertion tip. The connector
330 includes a substantially flat bottom surface 334 that extends
in a proximal direction to a sloping surface 366. When an insertion
tip is snap-fit onto the end of the connector 330, the flat
elongated surface 64 (FIGS. 3A and 3B) of the insertion tip
preferably contacts the flat bottom surface 334 of the connector
330. In one embodiment, the sloping surface 336 engages the sloping
surface 66 at the proximal end 52 of the tissue connector 50 (FIG.
3B).
The connector includes first and second connecting tabs 338, 340
that are adapted to advance into the opposing windows 62A, 62B of
the insertion tip 50 (FIG. 3B). The connector 330 also preferably
includes a raised protrusion 370 that engages the central lumen of
the insertion tip. In one embodiment, the central lumen of the
insertion tip is elastically deformed by the protrusion 370 on the
outer surface of the connector 330 as the insertion device moves in
a distal direction within the central lumen of the insertion tip.
The elastic deformation preferably returns to its original shape
when the protrusion 370 on the connector 330 reaches a recessed or
widened section toward the distal end of the central lumen of the
insertion tip. In one embodiment, the protrusion may reside on the
inside of the central lumen of the insertion tip and the
corresponding recess may reside on the distal end of the
connector.
Referring to FIGS. 17A and 17B, the protrusions 338, 340 adapted to
fit into the windows of the insertion tip preferably have a size
ranging from 0.002 inches to 0.030 inches, but preferably in the
range of 0.010 inches to 0.020 inches. The protrusions 338, 340 may
extend the full length of the windows in the insertion tip, or may
be of a shorter length depending upon the holding force required
between the insertion tip and the connector 330. In one embodiment,
the protrusions 338, 340 have a radial surface at a distal end of
the protrusions.
Referring to FIGS. 18A-18C, in one embodiment, a radial snap-fit
connector 430 is provided at a distal end of an insertion device.
The connector includes a pair of radial recesses 470A, 470B formed
therein, however, other embodiment may have only one radial recess
formed therein. In this embodiment, a central lumen of an insertion
tip desirably includes a pair of radial protrusions that are
adapted to fit into the recesses 470A, 470B for forming a snap fit
connection between the insertion tip and the connector 430. The
connector has a flat bottom surface 434 that is adapted to be
seated against the elongated flat surface 64 of an insertion tip
(FIG. 3B). The connector 430 includes a flat top surface 435 that
is adapted to be seated against the top wall 86 of the central
lumen 60 of the insertion tip (FIG. 3D). The radial snap-fit
connector 430 is preferably turned and machined, which allows for
ease of manufacture and customizing the fit for both locking and
unlocking.
The connectors 330, 430 shown and described in FIGS. 17A-17B and
18A-18C preferably have no moving parts. The snap-fit connectors
330, 430 may be made of plastic, metal or other suitable
materials.
Referring to FIG. 19, in one embodiment, an implant 542 preferably
has a central mesh region 544 and first and second suture loops
546, 548 that are connected with and extend from opposite ends of
the central mesh region 544. The implant 542 desirably includes a
first insertion tip 550A that is attached to the outer end of the
first suture loop 546 of the implant 542, and a second insertion
tip 550B that is attached to the outer end of the second suture
loop 548 of the implant 542. The insertion tips 550A, 550B are
preferably securable to the distal ends of insertion devices for
advancing the implant 542 through tissue for securing the implant
at a desired location within the tissue. In one embodiment, plastic
sheaths (not shown), such as those used with the Gynecare TVT
ABBREVO.TM. system, may be positioned over the insertion tips and
the distal ends of the insertion devices to provide for smooth
passage of the insertion tips and the insertion devices through
tissue. In one embodiment, the implant 542 preferably includes a
placement loop 551 with a button secured to the central region 544
of the implant. In one embodiment, the placement loop has a
monofilament loop of PROLENE.TM. suture with an attached
polypropylene button. The loop and the button are pre-assembled as
part of the implant at the center of the mesh to aid in the
placement of the central region 544 of the mesh under an
urethra.
While the foregoing is directed to embodiments of the present
invention, other and further embodiments of the invention may be
devised without departing from the basic scope thereof, which is
only limited by the scope of the claims that follow. For example,
the present invention contemplates that any of the features shown
in any of the embodiments described herein, or incorporated by
reference herein, may be incorporated with any of the features
shown in any of the other embodiments described herein, or
incorporated by reference herein, and still fall within the scope
of the present invention.
* * * * *
References